pharmaceutical regulatory resume

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Pharmaceutical regulatory resume write me academic essay on presidential elections

Pharmaceutical regulatory resume

Experienced in supporting a very wide portfolio of both pharmaceutical products and medical devices for prominently the Australian and New Zealand market. Track record of achieving exceptional results in supporting the launch of new products to market and in the life-cycle management of on-market products. Victoria Ramirez. Professional Summary.

Experienced in the preparation and registration of new products,including both sterile injectable generic pharmaceuticals and medical devices including consumables, electronic devices and software devices.

Experienced in liaising with TGA and Medsafe regulatory authorities for both pharmaceuticals and medical devices. Sound understanding of regulations, standards and legislation for Australia and New Zealand therapeutic products. Ability to work in a high pressured environment to meet stringent regulatory and corporate timelines. Extensive attention to detail and excellent written and communication skills Great track record of cross-functional collaborations with stakeholders internal and external to the business.

Represent regulatory in cross-functional collaborations with stakeholders internal and external to the business. What to Put on a Resume. How Long Should a Resume Be. The Best Resume Format. How to List Education. CV vs. Resume: The Difference. Include Contact Information.

How to Write a Student Resume. Product Stewardship Product Safety Classify chemicals per regulatory requirements Assist with development of standard operating procedures and work rules Assist with continuous process improvement for safety data sheet authoring process 5 years of relevant experience required Familiarity with SDS authority software, WERCs Familiarity with consumer goods manufacturing processes and safety issues Strong undergraduate coursework in Chemistry, including Inorganic Chemistry, Organic Chemistry and Calculus Product Stewardship and Product Safety professional experience Willing to accommodate local travel to meet with clients Masters degree preferred Previous employment with or involving a consumer goods manufacturing company i.

Drives the execution of said documents Monitor and submit applicable reports and responses to regulatory authorities Maintain annual licenses, registrations and listings Ensure compliance with product post-marketing approval requirements Review and approve required reports, supplemental submissions and other post marketing commitments Evaluate post-market incident reports and determine MDR requirements. Report adverse events to internal stakeholders Prepare and facilitate collection of necessary information for post-market health hazard evaluations, recall evaluations, MDR evaluations Provide regulatory input for UDI compliance requirements Minimum Education - Bachelor's degree in science biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology ; math; engineering; or medical fields is preferred Certification is a plus such as RAC from the Regulatory Affairs Professionals Society.

Combination product experience preferred Must have experience with US and European medical device submissions, regulations, and standards Must have directly authored k s and have experience in preparing other regulatory documents i. Cross-functional experience preferred Demonstrated ability to provide guidance and mentoring to less experienced colleagues and cross-functional team members.

Lead changes to the systems where required Lead divisional improvement activities and transactional LEAN projects. Prepare required documentation as needed e. Medical writing Advertising and promotion Labeling Controlled substances e. DEA Restricted substances e. Provide regulatory support and guidance to local and global internal networks Prepare and coordinate regulatory submissions for licensing and health authority engagement; prepare responses to health authority requests and apply valid scientific rationale to facilitate regulatory approvals and positive assessments.

An advanced degree or post-graduate Diploma or Certificate from a Regulatory Affairs program are assets Minimum 3 years of experience in Regulatory Affairs in regulated health products, food and beverage or CPG regulations.

This position requires a significant amount of initiative and judgment While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to use a computer, and communicate with peers and co-workers. Prepare regulatory submissions assuring that submissions are accurate, submitted on time, and gain approvals as scheduled Specific ability to file New drug applications NDA with clinical investigation requirements and abbreviated new drug applications ANDA Specific ability to file drug master files for active pharmaceutical ingredients Files supplements and annual reports as required for all active drug and medical device approved and pending applications Evaluates new product proposals presented by customers to assure that the product can be produced in a regulatory compliant manner Maintain organization of regulatory files to assure accurate responses to agency requests and maintenance of medical device design history files Maintain expertise regarding current and developing U.

Assist in developing regulatory strategies for the development and registration of medical devices and in vitro diagnostic kits Support preparation of complex submissions to gain approvals for clinical research and commercial distribution, such as: IDE, ITA, k , PMA, Design Dossier, Technical File, and Canadian Applications Manage assembly and submission of applications to regulatory bodies including FDA, Health Canada, and Notified Bodies Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations Evaluate documentation for clinical research and pre-market applications such as protocols, reports, scientific documents, labeling, risk documents, biocompatibility, ER checklists, clinical evaluations, etc.

Candidate can expect to spend a couple of days per month at our Newtown, PA office. Clinical study or epidemiology experience preferred Entry level accepted, years regulatory experience preferred Good written and oral English communication skills Good Computer skills: Outlook, Excel, Power Point Conscientious. Desirable experience in Medical Devices, Pharma background is acceptable. Professional certification s preferred Demonstrated success in management of regulatory submissions activities Thorough understanding of global regulations Strong technical knowledge of medical products Strong technical understanding of relevant procedures, practices, and associated medical terminology Strong knowledge of clinical trial strategy and study design, and sponsor reporting requirements Thorough knowledge of product development process and design control Excellent research and analytical skills Ability to effectively manage multiple projects Excellent written and oral communication, technical writing and editing skills Strong leadership, interpersonal and influencing skills.

Develop regulatory strategies for the development and registration of medical devices and in vitro diagnostic kits Prepare complex submissions to gain approvals for clinical research and commercial distribution, such as: IDE, ITA, k , PMA, Design Dossier, Technical File, and Canadian Applications Manages assembly and submission of applications to regulatory bodies including FDA, Health Canada, and Notified Bodies Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations Evaluate documentation for clinical research and pre-market applications such as protocols, reports, scientific documents, labeling, risk documents, biocompatibility, ER checklists, clinical evaluations, etc.

Handles and supervises product registration administration processes Updates the company on new regulations and procedures Maintenance of corporate databases Clinical Trial Application. Apply the Regulatory Foundation Must be a results-oriented team player capable of working in a fast paced environment with changing priorities Must be a self-starter able to work with minimal supervision, and able to perform under pressure and in ambiguous situations Must be organized and detail-oriented, with good analytical and decision making skills Must demonstrate effective verbal and written communications skills.

International regulatory medical device experience is a plus Strong decision making skills in ambiguous or unclear situations Demonstrated attention to detail and organizational skills Capable of effectively managing multiple projects with shifting priorities Ability to identify compliance risks and escalate when necessary Technical system skills e. Position provides regulatory support for the Smiths Medical site based in St.

Paul, Minnesota. Incumbent develop and prepare regulatory submissions, i. This individual proactively evaluates existing and emerging regulatory and quality requirements and directs implementation activities to minimize business exposure and guidance for interactions with government officials. This position is responsible for practicing Quality System Manual procedures and complying with its requirements, and carrying out responsibilities as outlined in safety, health and environmental policies Develop and prepare regulatory plans, submissions; specifically k Premarket Notification, PMA, IDE, Design Dossier, Technical Files, Australian Technical Files, Canadian Licensing, and Japan submissions.

Coordination of staff support for world-wide registrations for global growth and expansion Review and ensure regulatory compliance of internal operational and project documentation involved in commercial product release for all assigned projects. Prepare, maintain and ensure regulatory documentation supporting engineering activity is filed and readily available, keeping electronic lists, registers and directories up-to-date Participate as regulatory representative on project teams, communicate regulatory requirements and strategy.

Assist with data entry and analysis as needed, ensuring data quality and validity. Participate as Regulatory Representative on project teams Bachelor's degree in Science or Engineering or related field from an accredited college or university required. Ability to manage multiple projects and proficiency with Microsoft Office and software tools Ability to analytically assimilate regulatory information and updates and effectively convey these principles to appropriate cross functional departments and levels of management Ability to critically analyze information as it relates to regulatory submissions and clinical protocols Excellent verbal, written, and presentation communication skills.

Job title: Associate Regulatory Affairs Specialist Reporting to: Regulatory Affairs Manager Functional group: Market Access Ensures compliance with regulatory agency regulations and interpretations Prepares responses to regulatory agencies' questions and other correspondence Organizes and maintains reporting schedules for new drug application and investigational new drug Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides Provides solutions to a variety of problems of moderate scope of complexity Conducts searches of existing files for requested information Maintains and archives all regulatory documentation Bachelor Degree or above Minimum 2 years solid and reputable experience in regulatory affairs Proficiency in both spoken and written English and Chinese Essential — Market Knowledge Business Relationship Regulatory Environment Reimbursement Important — Ability to manage multiple projectsW.

Develops proficiency in any applicable regulatory requirement that applies to our products and ensures new or changed requirements are communicated within the organization Provides support to tender and importation requests in case of necessary regulatory documentation Follow up on Quality Requests, as assigned by the Regulatory Affairs Manager Ensure full alignment in all activities with relevant department process and company SOP i.

Track and report regulatory project status and informational documents appropriately Maintain submission correspondence files and other regulatory files in a complete and secure manner for regulatory and quality compliance. French is plus 1 - 2 years of administrative experience Computer literate. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies Prepare FDA submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release Provide support to currently-marketed products as necessary.

This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status. Provide on-going expertise to teams for regulatory issues and questions Provide comprehensive product information to worldwide peers for product introductions and training.

Review advertising, promotion and training materials. Provide support to currently marketed products as necessary. All significant issues will be reviewed by the manager Regularly communicates with senior management and regulatory agencies. Influence and inspire alignment with business goals, internally and externally Apply extensive technical or regulatory principles, theories and concepts and has full knowledge of other related disciplines Develop strategies that leverage opportunities and experiences across functions Develop technical solutions to complex problems that require the regular use of ingenuity and creativity.

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Experienced in liaising with TGA and Medsafe regulatory authorities for both pharmaceuticals and medical devices. Sound understanding of regulations, standards and legislation for Australia and New Zealand therapeutic products. Ability to work in a high pressured environment to meet stringent regulatory and corporate timelines. Extensive attention to detail and excellent written and communication skills Great track record of cross-functional collaborations with stakeholders internal and external to the business.

Represent regulatory in cross-functional collaborations with stakeholders internal and external to the business. Represent company in collaborations with regulatory authorities including reviewing agency released consultation documents Provide training and support to new staff. Ensure regulatory compliance of a very wide range of therapeutic products pharmaceutical products and medical devices.

Use of relevant electronic tools and programs internal and external to business operations. Compiling Annual Product Quality Reports for regulatory. Lead in driving timely assessment and delivery of reports. Cross-functional experience preferred Demonstrated ability to provide guidance and mentoring to less experienced colleagues and cross-functional team members. Lead changes to the systems where required Lead divisional improvement activities and transactional LEAN projects.

Prepare required documentation as needed e. Medical writing Advertising and promotion Labeling Controlled substances e. DEA Restricted substances e. Provide regulatory support and guidance to local and global internal networks Prepare and coordinate regulatory submissions for licensing and health authority engagement; prepare responses to health authority requests and apply valid scientific rationale to facilitate regulatory approvals and positive assessments.

An advanced degree or post-graduate Diploma or Certificate from a Regulatory Affairs program are assets Minimum 3 years of experience in Regulatory Affairs in regulated health products, food and beverage or CPG regulations. This position requires a significant amount of initiative and judgment While performing the duties of this job, the employee is regularly required to be independently mobile.

The employee is also required to use a computer, and communicate with peers and co-workers. Prepare regulatory submissions assuring that submissions are accurate, submitted on time, and gain approvals as scheduled Specific ability to file New drug applications NDA with clinical investigation requirements and abbreviated new drug applications ANDA Specific ability to file drug master files for active pharmaceutical ingredients Files supplements and annual reports as required for all active drug and medical device approved and pending applications Evaluates new product proposals presented by customers to assure that the product can be produced in a regulatory compliant manner Maintain organization of regulatory files to assure accurate responses to agency requests and maintenance of medical device design history files Maintain expertise regarding current and developing U.

Assist in developing regulatory strategies for the development and registration of medical devices and in vitro diagnostic kits Support preparation of complex submissions to gain approvals for clinical research and commercial distribution, such as: IDE, ITA, k , PMA, Design Dossier, Technical File, and Canadian Applications Manage assembly and submission of applications to regulatory bodies including FDA, Health Canada, and Notified Bodies Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations Evaluate documentation for clinical research and pre-market applications such as protocols, reports, scientific documents, labeling, risk documents, biocompatibility, ER checklists, clinical evaluations, etc.

Candidate can expect to spend a couple of days per month at our Newtown, PA office. Clinical study or epidemiology experience preferred Entry level accepted, years regulatory experience preferred Good written and oral English communication skills Good Computer skills: Outlook, Excel, Power Point Conscientious. Desirable experience in Medical Devices, Pharma background is acceptable.

Professional certification s preferred Demonstrated success in management of regulatory submissions activities Thorough understanding of global regulations Strong technical knowledge of medical products Strong technical understanding of relevant procedures, practices, and associated medical terminology Strong knowledge of clinical trial strategy and study design, and sponsor reporting requirements Thorough knowledge of product development process and design control Excellent research and analytical skills Ability to effectively manage multiple projects Excellent written and oral communication, technical writing and editing skills Strong leadership, interpersonal and influencing skills.

Develop regulatory strategies for the development and registration of medical devices and in vitro diagnostic kits Prepare complex submissions to gain approvals for clinical research and commercial distribution, such as: IDE, ITA, k , PMA, Design Dossier, Technical File, and Canadian Applications Manages assembly and submission of applications to regulatory bodies including FDA, Health Canada, and Notified Bodies Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations Evaluate documentation for clinical research and pre-market applications such as protocols, reports, scientific documents, labeling, risk documents, biocompatibility, ER checklists, clinical evaluations, etc.

Handles and supervises product registration administration processes Updates the company on new regulations and procedures Maintenance of corporate databases Clinical Trial Application. Apply the Regulatory Foundation Must be a results-oriented team player capable of working in a fast paced environment with changing priorities Must be a self-starter able to work with minimal supervision, and able to perform under pressure and in ambiguous situations Must be organized and detail-oriented, with good analytical and decision making skills Must demonstrate effective verbal and written communications skills.

International regulatory medical device experience is a plus Strong decision making skills in ambiguous or unclear situations Demonstrated attention to detail and organizational skills Capable of effectively managing multiple projects with shifting priorities Ability to identify compliance risks and escalate when necessary Technical system skills e. Position provides regulatory support for the Smiths Medical site based in St. Paul, Minnesota. Incumbent develop and prepare regulatory submissions, i.

This individual proactively evaluates existing and emerging regulatory and quality requirements and directs implementation activities to minimize business exposure and guidance for interactions with government officials. This position is responsible for practicing Quality System Manual procedures and complying with its requirements, and carrying out responsibilities as outlined in safety, health and environmental policies Develop and prepare regulatory plans, submissions; specifically k Premarket Notification, PMA, IDE, Design Dossier, Technical Files, Australian Technical Files, Canadian Licensing, and Japan submissions.

Coordination of staff support for world-wide registrations for global growth and expansion Review and ensure regulatory compliance of internal operational and project documentation involved in commercial product release for all assigned projects. Prepare, maintain and ensure regulatory documentation supporting engineering activity is filed and readily available, keeping electronic lists, registers and directories up-to-date Participate as regulatory representative on project teams, communicate regulatory requirements and strategy.

Assist with data entry and analysis as needed, ensuring data quality and validity. Participate as Regulatory Representative on project teams Bachelor's degree in Science or Engineering or related field from an accredited college or university required. Ability to manage multiple projects and proficiency with Microsoft Office and software tools Ability to analytically assimilate regulatory information and updates and effectively convey these principles to appropriate cross functional departments and levels of management Ability to critically analyze information as it relates to regulatory submissions and clinical protocols Excellent verbal, written, and presentation communication skills.

Job title: Associate Regulatory Affairs Specialist Reporting to: Regulatory Affairs Manager Functional group: Market Access Ensures compliance with regulatory agency regulations and interpretations Prepares responses to regulatory agencies' questions and other correspondence Organizes and maintains reporting schedules for new drug application and investigational new drug Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides Provides solutions to a variety of problems of moderate scope of complexity Conducts searches of existing files for requested information Maintains and archives all regulatory documentation Bachelor Degree or above Minimum 2 years solid and reputable experience in regulatory affairs Proficiency in both spoken and written English and Chinese Essential — Market Knowledge Business Relationship Regulatory Environment Reimbursement Important — Ability to manage multiple projectsW.

Develops proficiency in any applicable regulatory requirement that applies to our products and ensures new or changed requirements are communicated within the organization Provides support to tender and importation requests in case of necessary regulatory documentation Follow up on Quality Requests, as assigned by the Regulatory Affairs Manager Ensure full alignment in all activities with relevant department process and company SOP i. Track and report regulatory project status and informational documents appropriately Maintain submission correspondence files and other regulatory files in a complete and secure manner for regulatory and quality compliance.

French is plus 1 - 2 years of administrative experience Computer literate. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies Prepare FDA submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release Provide support to currently-marketed products as necessary.

This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status. Provide on-going expertise to teams for regulatory issues and questions Provide comprehensive product information to worldwide peers for product introductions and training.

Review advertising, promotion and training materials. Provide support to currently marketed products as necessary. All significant issues will be reviewed by the manager Regularly communicates with senior management and regulatory agencies. Influence and inspire alignment with business goals, internally and externally Apply extensive technical or regulatory principles, theories and concepts and has full knowledge of other related disciplines Develop strategies that leverage opportunities and experiences across functions Develop technical solutions to complex problems that require the regular use of ingenuity and creativity.

Expert problem solving skills and experience with complex issues that require resolution. Ability to work independently and make decisions that have significant impact to the company. Acts on own initiative to identify opportunities and propose solutions outside the scope of their job responsibility. Strong interpersonal skills Demonstrated ability to define problems and provide guidance to management in developing and implementing solutions Analytical and creative thinking skills and the ability to solve complex problems Or-.

Related Job Titles. Regulatory Affairs Analyst Resume Sample. Regulatory Compliance Specialist Resume Sample. Regulatory Affairs Manager Resume Sample. Regulatory Affairs Resume Sample. Regulatory Affairs Officer Resume Sample. Regulatory Affairs Associate Resume Sample. Regulatory Specialist Resume Sample.

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The section contact information is important in your regulatory affairs associate resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your: First and last name Email Telephone number. The section work experience is an essential part of your regulatory affairs associate resume. This section, however, is not just a list of your previous regulatory affairs associate responsibilities.

It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular regulatory affairs associate position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Regulatory Affairs Associate resume experience can include: Excellent oral and written communications skills required. Organization skills in prioritizing and managing multiple projects Excellent communication skills and ability to effectively present scientific data both in writing and verbally to management Demonstrates effective, self-sufficient communication skills, especially in peer-directed presentations Communication skills to effectively build relationships with key clients, stakeholders and members of government departments Excellent written and spoken communications skills, with confidence in building strong scientific justifications Excellent planning, organizational, analytical, problem-solving, proofreading, and decision-making skills.

Make sure to make education a priority on your regulatory affairs associate resume. For example, if you have a Ph. D in Neuroscience and a Master's in the same sphere, just list your Ph. When listing skills on your regulatory affairs associate resume, remember always to be honest about your level of ability. Include the Skills section after experience.

Present the most important skills in your resume, there's a list of typical regulatory affairs associate skills: Accomplished interpersonal skills to work effectively in a team environment and act as a liaison with other departments Negotiation and communication skills to effectively build relationships with key clients, stakeholders and members of government departments Experience and comfort working independently and as part of a team on multiple projects with ability to prioritize effectively Complying with constantly changing regulatory procedures; reprioritizing work effectively Possess strong written and verbal communication skills and advanced word processing and formatting Very good negotiating, communication and influencing skills.

Resume Resume Examples Resume Builder. Create a Resume in Minutes. Celestine Rowe. Regulatory Affairs Associate. Senior Regulatory Affairs Associate. Global Regulatory Affairs Associate. You lead and coordinate pharmaceutical development activities formulation, pharmaceutical processes incl. Assists the Sr. This assistance includes tasks such as gathering tools, machine parts, and documents required for such activities.

Retrieves components and equipment from aseptic storage Assists with Isolator and room cleaning in production areas. Will transfer rubbish to the transfer zones and may empty transfer zones of rubbish when required. This includes removal of equipment, room sanitization and disposal of waste according to established safety requirements Responsible for performing filling operations and assisting in visual inspection operations Ensures components, materials and supplies are stocked prior to the start of the filling operations.

Technicians must maintain their skills and knowledge current with the advances in the field of pharmaceutical development Incumbents may attend internal or external training courses as approved by management Lilly does not anticipate providing sponsorship for employment visa status e. Evaluating the physical and chemical characteristics of raw materials, intermediates, APIs, and drug products utilizing approved laboratory methods or developing new methods Executing analytical methods and test procedures in accordance with written processes.

This includes the characterization, potency, moisture, and purity of reference standards and the preparation, packaging, testing, and inventory maintenance of working standards. Supports vendor contracted to manufacture standards as appropriate Performs qualitative and quantitative analytical tests utilizing approved protocols and test procedures in support of the Stability Testing Program for APIs and drug products Documents laboratory activities and maintains laboratory notebook.

A High School diploma or GED is required At least 1 year of work experience in a GMP Good Manufacturing Practice facility is preferred At least 1 year work experience in oral solid dosage manufacturing blending, compression, pan coating, fluid bed or encapsulation manufacturing processes is preferred Flexibility to work a non-traditional shift is required We are hiring for the following shifts. Specific responsibilities include but are not limited to the following Provide on floor support to ensure data integrity and compliance with sampling of raw materials and inspection of primary packaging components Support regulatory audits Submit Work Orders to maintain compliance within sampling and component facilities Update Supplies Inspection protocols, logbooks, etc.

Evidence of good oral and written communication skills, i. Basic understanding of GMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area. Preferred Experience and Skills Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is a strong plus. H1-B status now or in the future. Prepare concise and well-written reports, memos, proposals, and white papers Maintain security and confidentiality of all protected health information encountered during performance and other essential functions Lead meetings, team projects, training on hot topics in the industry, and discuss current topics with clients and inter-professional team Listen and communicate effectively Mentor APPE pharmacy rotation students Collaborate with and understand a wide variety of healthcare professionals, including but not limited to: pharmacists, pharmacy technicians, pharmacy students, other healthcare professionals, educators, and payer drug coverage decision makers Articulate and know where to access the drug-pricing spectrum—including but not limited to a variety of drug pricing schemes, both on the manufacturer, wholesaler, as well as payer sides of pharmacy.

Pharmaceutical sales background Project Management Experience Preferred Experience or interest in Multichannel approach Ability to plan strategically and logically Knowledge of the drivers surrounding Community Pharmacy High level of ability and experience in planning, preparation, and presentation High-level numeric skills and demonstrates initiative ABPI Qualified Degree level education or equivalent Full EU Driving licence no more than 6 points Eligible to work full-time in the UK.

IMM diploma 3 South African citizenship, 4 A valid unendorsed driver's licence and 5 Your own car or access to a vehicle. Petersburg, FL This position is not eligible for relocation assistance. Our internships will start between mid-June to August for a duration of 12 months We are currently advertising multiple internship opportunities within the UK; please apply for the role against which you best meet the qualifications and requirements Please note that if your skills or experience could be suitable for other internship opportunities we will also consider you for these without you needing to submit a further application The closing date for applications is the 5th December However we review all applications on a rolling basis and therefore advise you to apply as soon as possible.

Assess talent needs and identifies talent within the GMT organization Work with other team leaders on sharing of technical knowledge across the network and encourage others to share knowledge. Formulation, manufacturing including GMP pilot plant , analytical testing and clinical supply functions totaling more than staff, report to this position. Provides oversight and approval of all technical documentation prepared and submitted to regulatory authorities in support of respiratory product development activities Proactive leader of the Mylan Global Respiratory Group leadership team, helping set the strategic direction of the group Exerts external influence across the industry and on respiratory topics of interest to ensure Mylan's needs and views are represented.

Retrieves components and equipment from storage Assists the Sr. Problems may include, but are not limited to mechanical issues, component issues Performs all work in accordance with Company Policies and Procedures. All activities are to be documented in the batch record. All events are to be recorded in the batch record and brought to the attention of the production supervisor for further action Assists with room cleaning in production areas.

This includes removal of equipment, room sanitization and disposal of waste according to established safety requirements Responsible for following controlled documents to ensure that the equipment identified for operations are used and documented. This includes verification of equipment calibration. Actively participates in the identification and implementation of manufacturing procedure improvements intended to optimize existing or new processes and ensure achievement of regulatory and safety requirements.

Initiates lean manufacturing techniques in order to actively reduce process and change-over cycle times Identifies areas for Continuous Process Improvement and applies operational excellence tools to reduce process variability and steadily deliver measurable efficiency gains Actively participates in troubleshooting and deviation investigations as assigned Reports findings to management team and team members with recommendations for improvement.

Responsible for development of training materials for new equipment and for review of training materials for current equipment. Completes all required training on time. Is qualified to conduct on the job training in packaging. Specialist will be determined based on skills and experience.

Drive sales performance and ensure sales forecasts and assigned budgets meet or exceed therapeutic and territory expectations Provide special education to healthcare providers through appropriate programs that fall within AstraZeneca's ethical guidelines Work with other Pharmaceutical Sales Specialists around common objectives to coordinate selling efforts Provide timely and competent administrative management of work hours, sales call data, customer objectives, communication responses, synchronization, sample and expense reporting.

Call on physicians in hospital settings, and residency and fellowship programs within a defined geographic territory Responsible for positioning AstraZeneca as a leader in Oncology commitment through development of long term relationships with Key Customers Work with RAD and District Sales Managers to develop and direct sales strategies at key accounts assigned in the territory Develop and direct sales strategies at key accounts assigned in the territory Develop and implement clinical sales presentations to groups of healthcare personnel during medical meetings, and the general public in health fairs and support groups Experience selling and knowledge of Oncology products or diseases preferred.

Breast and lung cancer drug sales experience strongly preferred for Oncology positions Demonstrated clinical selling skills Demonstrated ability to manage PREP budget and to work through the PRA process Knowledge of medical office equipment, territory management direct and in-direct sales processes Possess excellent written and verbal communications skills, and presentation skills Business administration skills Laptop computer skills Managed Care knowledge including prior authorization successes, demonstrated understanding of managed care contracting Proven ability to understand, internalize, and routinely present challenging scientific information Effective communication abilities to include strong group presentation skills Ability to freely accept, implement, and exchange best practices.

Achieve and exceed sales goals while managing a budget using good judgment Regularly use a variety of analytical tools to understand and evaluate the business in order to best determine how to accomplish sales objectives Develop and maintain in-depth knowledge of market, demographic, and managed care information relative to assigned sales territory Be results oriented with demonstrated time.

At least two years of documented, full-time, successful pharmaceutical sales Strong clinical skill, and sales ability Internal candidate must be Career Ladder Level 2 and above Four or more years in AZ Pharmaceutical Sales Internal Only , or related sales experience, preferably in the anti-platelet, cardiovascular, gastrointestinal, and respiratory markets Experience in working with interventional cardiologist.

Work with Regional Sales Director and District Sales Manager to develop a local strategy and business plan to generate recognizable increases of sales in territory Respiratory specialty marketplace experience preferred or other demonstrated Respiratory therapeutic experience preferred in addition to the requirements listed above Demonstrated strong capability in account management and proven sales performance track record Demonstrated understanding of the business drivers, dynamics, regulations and market access environment within the pharmaceutical industry Effectively use active listening, probing and other selling skills to enhance communication and build and influence key customers.

At least two years of documented, successful pharmaceutical sales, or at the discretion of those involved in the hiring process, related sales to physicians and hospitals such as medical equipment Experience selling and knowledge of Oncology products or diseases preferred History of building and influencing customer relationships, and goal achievement Demonstrated clinical selling skills and business acumen in complex selling environment.

Responsible for selling, maintaining and documenting all sales activities for the AstraZeneca Oncology portfolio of products to physicians in private practice, in group practices, in hospital settings, and Oncology residency and fellowship programs within a defined geographic territory Maintain a high level of clinical expertise by consistently utilizing all available medical information resources Develop and implement clinical sales presentations to groups of healthcare personnel Maximize key physician contact by networking within accounts and at all medical meetings.

Supervise the day to day security operations of an assigned Client Site Build, improve and maintain effective relationships with both client and employees Ensure all required reporting and contract compliance requirements are met Communicate staffing needs via Requisition Form; assist recruiters in identifying, interviewing and hiring quality candidates Develop staff in both technical and professional skills through performance management coaching, counseling, disciplining, MSO training, annual formal performance evaluations, recognition, etc.

Assure that employee grievances are heard and resolved with help from appropriate support employees, as required and that personnel records are updated and accurate Change of Status forms, rosters, etc. Ensure complete customer satisfaction Capably utilize WinTeam for scheduling and billing, and to produce reports such as Scheduling Activity, invoice Aging by tiers, Training Summary and Training Detail reports that require interpretation and action for effective business management Enforce AlliedBarton policies as outlined in the handbooks, executive memos and on the portal Four year degree in Criminal Justice, Business Administration or related field Outstanding interpersonal and communications skills required Ability to manage multiple priorities, complex situations, a diverse team of employees and client requirements on an ongoing basis.

Two or more years Hospital selling experience Experience working in the Cath Laboratory Experience influencing formulary decisions. Bachelor's Degree or equivalent Five years of pharmaceutical sales representative experience with the last 3 years in a Diabetes sales role Account management experience Preferred Diabetes Sales experience Demonstrated effective leadership, organizational and communication skills. Evidence of strong established relationships with local endocrinology specialists Understanding of the business drivers, dynamics, regulations and market access environment within the pharmaceutical industry Skills at building and maintaining professional relationships with key customers, office staff and others in the customer influence network Strong business analytics to analyze data as well as develop, execute and adjust business plans Ability to work in matrix teams.

Knowledge of automated Materials Requirement Planning i. MES system preferred Demonstrated ability to communicate positively with personnel at all levels Demonstrated ability to collaborate with others in cross-functional settings Proven organizational, analytical and problem solving skills are required to appropriately balance short-term business demands 3rd Shift Position Sunday through Friday pm to am.

Can represent PS viewpoint at divisional level Resource Management — Ability to anticipate and manage internal and external resource needs people, information, technologies, time, and capital Willingness to travel to various meetings or client sites, including overnight trips. Work with the other pharmaceutical operators and supervisors in assigned area to establish priorities and meet deadlines. Ensure safe work environment by following all safety procedures, workplace standards and company guidelines, and ergonomic rules, including proper use of personal protective equipment PPE , standard operating procedures SOPs applying to a particular process or area, Current Good Manufacturing Practices cGMPs , Occupational Safety and Health Administration requirements OSHA , Lockout Tagout Maintain, clean, and organize work area and participate in safety improvement projects.

Properly dispose of waste product and containers Dispense components, operate, clean, set-up, changeover and maintain equipment and rooms to manufacture products. Clean and maintain process equipment which may include, but not limited to tanks, filler, pumps, blenders, mills, presses, coating pans, etc Assist with technical troubleshooting and preventive maintenance tasks as needed and trained. Maintain daily production sheets and time sheets for team Take ownership of training and learning to develop high performance competencies such as technical skills, communication skills, and skills to build a team-oriented culture i.

Cross train and train other pharmaceutical operators on equipment and processes as needed Participate in on-going medical surveillance programs as required Perform other duties as trained and assigned Must be physically able to operate a forklift truck; forklift truck experience. Develops Hub strategy Demonstrates technical selling skills and BriovaRx service model expertise Collaborates with pharmacy operations team to ensure superior customer service Analyzes and summarizes data and trends Routinely communicates with centralized marketing team regarding resources, competitive activity, etc Interfaces with biopharmaceutical manufacturers to highlight BriovaRx's service excellence Builds business relationships with health care professionals Updates job knowledge by participating in educational opportunities; reading professional publications; participating in professional organizations Maintains accurate records of all sales activities including salesforce.

Hands on experience on pharmacy batch project. Has the ability to write and review documents for regulatory filings May publish or present externally. Order pharmaceuticals and supplies for the pharmacy Maintain all backorder information. Research and maintain statistics of all items missing from the pharmacy floor Compile monthly reports on performance against targets and monitor, track and report pharmacy inventory monthly Special projects as assigned 3 — 5 years of relevant work experience Strong organizational skills and problem solving skills; Strong math skills; Demonstrated ability to meet multiple deadlines and manage heavy workload; Excellent verbal and written communication skills; Contracting experience preferred.

Empty to kg max. Provide vision and leadership to establish clear goals and expectations of the department in alignment with portfolio and corporate objectives. Is a member of the Small Molecule Development leadership team Develop, implement, and monitor practices, policies and strategies for the department to support the small molecule portfolio.

Ensure that projects receive necessary resources and scientific support. Efficiently partner with other departments locally and globally Develop and implement short, mid, and long term strategies to ensure scientific excellence, state-of-the-art technologies, and regulatory compliance. Influence evolving regulatory standards through participation in professional and trade organizations Ensure and monitor laboratory compliance with current Good Manufacturing Practices cGMPs , Standard Operating Procedures SOPs and regulatory requirements for development and line-extension projects.

Ensure technical training of personnel is current and that laboratories are using current and state-of-the-art methods in accord with industry and regulatory standards. Ensure proper qualification, validation, and maintenance of all equipment Provide professional development opportunities for all personnel.

Conversely, facilitate evaluation, recommendations and decision-making on client accounts and opportunities of lower investment priority Lead capture strategies for key pursuits and major projects within the regional market and ensure those strategies yield high capture rates Lead market specific external affairs and branding activities that promote AECOM Provide analysis and performance forecasts against business plans, and when necessary make timely adjustments of priorities to achieve plans Ensure the proper staffing of Key Account positions, in coordination with the National Market Sector Director Provide mentoring and coaching to Key Account Managers Advanced degree in Environmental related studies Sales and marketing experience.

Take ownership of personal training and learning to develop skills to continuously improve processes Help build team-oriented culture by motivating and supporting team members by sharing knowledge with all members of the factory to continuously improve the process Work with the other pharmaceutical operators and supervisors in that area to establish priorities and meet deadlines Properly dispose of waste product and containers Inform department administrative assistant when to order supplies as needed May perform other duties as assigned At least 6 months experience using motorized and non-motorized material handling equipment At least 6 months experience using automated inventory system or equivalent computer systems i.

Must be able to fluently read, write, and speak English Proven ability to work safely in a production environment Proficient mathematical skills and familiarity with the metric system Demonstrated knowledge of Windows and Lotus Notes Previous experience in a government regulated i. Responsible for the let down process to ensure that sufficient quantities of product are in the pick location Maintain cleanliness and organization of pharmacy storage areas Advise inventory analyst of out-of-stock or short dated items upon discovery and rotate stock as necessary Ensure all shipments are labeled correctly Maintain effective communication with customers, co-workers, and other team members Maintain all material handling equipment and report any potential problems Skill in operating a fork lift vehicle Technical skills — able to operate a fork lift vehicle and a motorized pallet jack.

Familiarity with industry-standards such as ICH, IMPD, XEVMPD, Experience with the software development lifecycle, specifically in a validated environment Experience owning a defined portion of a project, and a demonstrated ability to manage issues and risks, with an understanding of appropriate and timely escalation Experience managing client and vendor relationships.

The abilityto identify and articulate the value of new business opportunities. Responsibilities may include strategy and process design in the following areas. Government-funded cooperating agencies and contractors, host-country counterparts and government officials, USAID Mission staff, and representatives from other key stakeholders such as NGOs and other donors Experience working with USAID, Global Fund, or other donors supplying healthcare commodities highly preferred Demonstrated leadership, versatility, and integrity Excellent verbal and written English communication and presentation skills are required; fluency in a second language is highly desirable.

Contribute to research experiments to 1. Criteria of strategic importance to the client are often included in the contract as well, and typically define additional commitments required of CH2M HILL to achieve delivery success e. Present the Pharma vision at client presentations, industry conferences Meet with clients to review drug plan design and performance Develop strong relations with the various provincial governments to represent our customers best interests e.

Plans, schedules, directs, evaluates, and manages the complex day-to-day work of manufacturing associates to meet the department goals in terms of quality, productivity and efficiency under cGMP conditions. Proactively identifies and manages quality and compliance deviations, and ensures that corrective actions are implemented.

Responsible for conducting pre-campaign risk assessments for the shift team, and compiling post campaign lessons learned. Modifies plans and procedures to suit business demand based on production results Coaches and develops complex operations and skilled technical staff through talent and performance management of all direct reports. The manager will also develop and maintain resource planning tools in order to project staffing needs and manage cost for the shift team.

The manager will work with internal and external staffing recruiters to manage head count needs for the shift team. Further, the position will be responsible for identifying critical gaps in staff training and establishing a development plan for all direct reports that is in line with the overall department goals Ensures work environment related to assigned area of manufacturing meets company and industry standards and compliance regulations.

Leads the development of compliance and safety goals for direct reports. Reviews any issues related to manufacturing performance, process and safety in order to ensure safety, compliance with regulations and cGMPs. Responsible for driving and facilitating continuous process improvement to meet department needs. Develops and maintains Key Performance Indicators KPI in order to monitor health of the shift and drive performance management within shift team.

Responsible for investigating, developing and evaluating potential solutions to identified safety issues Continuously evaluates process performance to identify areas of improvement, and collaborate in developing protocols to achieve same. Evaluates and applies modern operational excellence tools to reduce process variability and steadily deliver measurable efficiency, productivity or quality gains Collaborates within department and cross-functionally to meet set objectives.

Represents Filling and Visual Inspection on cross functional teams and gains alignment on day-to-day manufacturing issues and needs Leadership experience preferred. Managing teams through the design and implementation of people, process and technology changes, including building solid and collaborative relationships with team members, fostering a productive teamwork environment, leveraging diverse views to encourage innovation, and helping develop and grow team members throughout the course of every engagement, providing timely and meaningful feedback Exhibiting capability in thought leadership, development of intellectual property IP , and marketing and promotion of IP Supporting incremental business development opportunities, and where possible, identifying new business opportunities, including client lead maturation, proposal development, and close.

Leveraging industry contacts to make introductions and connect the firm to potiential clients short term or long term. Maintaining an active rolodex and pipeline of executives and working to maintain, expand, and mature those over time Identifying and addressing client needs: build, maintain, and utilize networks of client relationships; manage resource requirements, project workflow and budgets Communicating complex material effectively in written and oral formats to various audiences Conducting and directing quantitative and qualitative analyses of large and complex data.

Administers the receipt, validation, and payment of rebate claims for branded NDCs from insurers, prescription benefit managers PBMs , and at- risk Medicaid organizations accounts Reads and interprets contract terms and conditions concerning rebate eligibility and set parameters in the proprietary contract system CARS to accurately calculate each rebate Processes each claim in accordance with contract language and internal processing procedures Understands all systems and processes and strives to identify improvements Assists manager in training and development of claims administration staff Reviews and interprets rebate contract terms and conditions and establishes parameters in the contracting system CARS to produce accurate rebate calculations Conducts initial quality check, including formulary compliance, on all claim submissions to ensure rebate eligibility.

Resolves issues with account and prepares validation system ECP to receive detail claim data Reviews suspect claim records and determines if record should be disputed for payment. Communicates disputed records to account Prepares contracting system to receive validated claim data and calculate rebates.

Development and execution of a Pharma manufacturer engagement strategy. Developing and successfully implementing strategies and action plans for establishing and enhancing a competitive contracting approach for Cigna which meets current and future needs of our customers and clients Build and direct effective strategic relationships, contracting initiatives, and strategies with both brand and generic pharmaceutical manufacturers Continually explore market to develop new contracting opportunities.

Maintain and educate organization on industry trends, risks, and opportunities Strategically partner with CIGNA Pharmacy Management Clinical Program Management to align contracting options to meet client requirements, coverage criteria and formulary strategy Lead a team of contracting professionals in their daily work Strong analytical background, business oriented, strategic thinking capabilities and attention to detail, while maintaining a "big picture" view.

Possesses a comprehensive understanding of functional areas and the impact on overall performance. Has the ability to see business needs outside of ones own work area and to drive a cross-functional agenda Excellent written and oral communication skills. Manages relationships and service delivery for assigned books of business. Serve as a resource and point of escalation for assigned clients and staff. Collaborates with several internal Walgreens departments to ensure client satisfaction is achieved through the best service possible to help drive retention and increase sales.

Resolve manufacturer customer issues by working internally with appropriate key operational teams Manages customer relationship with key strategic pharmaceutical and biotech accounts. Minimum education BSc. In Biology, chemistry or related fields Experience: 5 years pharmaceutical testing experience.

Proven time management skills. Managing multiple assignments Deliver results in a timely manner Proven track of working well with others Excellent written and verbal communications Candidates must be proficient in using various type of computer software Word, Excel, PowerPoint, Outlook etc.

Bachelor's degree or higher in a Science or Engineering discipline from an accredited institution Minimum of three 3 years clinical research experience Experience in one or more of the following areas: clinical study coordination, pharmaceutical development, clinical trial management including contracts, clinical trial project management Demonstrated experience in computer skills including Microsoft Word and Excel Good organizational, IT, and administrative skills as the job involves a lot of documentation and recording of information through computerized processes Ability to work effectively on cross-functional teams.

Develop innovative purchasing programs Identify market opportunities and risks Ensure adherence to the sourcing program Support resolution of supplier operational issues Resolve product supply issues Coach and develop the team Create and manage budgets and forecasts. Perform Investigations and determine and implement long lasting corrective and preventative actions Monitor process performance, identify gaps, and implement corrective actions to achieve and sustain agreed upon performance Foster and maintain a continuous process improvement mentality within the group Foster and maintain Communication within the group Be able to coordinate activities with other groups and management Lead the implementation of CAPA items Operate assigned equipment and processes, as needed Review and Approve Batch Records and other Documentation Create Processes and Procedures Supervise the technical set up and technical personnel's activities for the Filling, Capping, Participating in pre-FAT testing for new production equipment.

This will require some Mechanical aptitude is a must Leadership and communication verbal and written skills and ability to be part of team The clean room manufacturing environment requires personnel with good personal hygiene Adaptability to change and to perform under pressure with time constraints Bachelors Degree and a minimum 3-years supervisory experience, preferably in the pharmaceutical industry Must have aseptic pharmaceutical experience Experience in a manufacturing environment or advanced mechanical training is a plus.

Identify, qualify and develop new opportunities with current and new customers, based on Siemens Portfolio Develop and maintain knowledge of competitive products and create sales support materials to promote Siemens products vs. Communicates staffing needs on shift to Account Manager or Operations Manager Assures that officers receive appropriate training, developing them in both technical and professional skills; also may As a condition of continued employment, employee must maintain current active status of all required License at all times,.

Drive product launches with communication and training. Ensure that new products are introduced professionally, with appropriate positioning, pricing, sales materials, promotions and accompanying services. Marketing manager to develop new marketing initiatives that contribute Avery Dennison China business. Leading the preparation of regulatory strategies and regulatory submissions e. Lead cross-functional teams to implement client solutions w Leverage and customize proprietary analytics to client needs, resulting in exceptional client value Manage multiple projects ensuring exceptional client satisfaction and on-time delivery Make presentations and recommendations to clients on optimal customer, sales and marketing strategies and tactics Contribute to development of new solutions and analytical models Manage and mentor a team of analysts.

The Contractor Quality Analyst CQA provides Quality support to the Incoming Material Supplies Inspection processing and laboratory areas The CQA, with guidance from the Incoming Materials IPT Quality Leadership Team, will perform activities that support and ensure process quality and data integrity with incoming sampling of raw materials and inspection of primary packing components The Contractor Quality Analyst will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance, and will train on and gain competency in activities to support incoming sampling in Classified D and C processing areas and component inspection Support regulatory audits Submit Work Orders to maintain compliance within sampling and component facilities Update Supplies Inspection protocols, logbooks, etc.

Assures that all safety information such as MSDSs are available for all lab personnel The incumbent may be called upon to perform other tasks to support the attainment of business objectives The incumbent is responsible for mentoring less experience lab personnel in good documentation practices notebook, investigative and other technical report writing, annotating and archiving supporting data, maintaining procedural formats, etc.

Writes technical documents such as methods, specifications, validation protocols and reports, transfer protocols and reports based on corporate policies and SOPs, compendial, ICH and FDA regulatory guidance Ensures that the integrity and accuracy of all laboratory documents are maintained Assess overall document compliance with protocols, SOPs, company policies, and applicable regulations Evaluates compendial documents and reviews procedures for analytical development and validation Reviews Drug Master Files DMFs of active ingredients and provides essential information to laboratory personnel Reviews analytical data for accuracy, completeness and compliance to cGMPs and established laboratory documentation standards Generates change requests required for analytical documents and routes documents for review and approval.

Assigns document numbers. Unique industry offering learning and growth opportunity Competitive benefits offered day-one on the job PTO days offered day-one Tuition assistance plus great training programs day-one 12 hour rotating shifts offer flexibility.

Sole contributor or leader of a small team to deliver IT solutions that allow the business to reach its strategic objectives and are implemented in a cost efficient and high quality manner Has authority and responsibility for a significant area of work, including technical, financial and quality aspects. When appropriate, leads organizational objectives and delegates responsibilities. Ensures documentation according to Takeda QMS standards, policies and procedures Leads requirements gathering, prioritization and negotiation with business management on a BU level Is a subject matter expert in the business area of expertise, understands one or more BU organisations and related technical landscapes Responsible for delivery of large-scale changes and delivery of IT projects Makes decisions which impact the work of employing organizations, achievement of organizational objectives and financial performance Influences policy formation on the contribution of own specialism to business objectives.

Influences a significant part of own organization. A good knowledge of cGMP and regulatory requirements Relating to the pharmaceutical industry is required Experience of operating in a highly automated environment and safe handling of Dangerous chemicals is required Good I. Petersburg, FL and other international locations as needed. Experience with the software development lifecycle, specifically in a validated environment Prior supervisory and people development experience.

Handling of finished product Manipulation of drums to and from 6-inch pallets up to 80 lbs. Perform required employee performance appraisals. Financial management throughout the life cycle of an event Planning, coordination, and execution of group air travel including any applicable transfers Use resource efficiently and maximize productivity by utilizing the relevant technology. Starcite or Cvent. Returns materials and allocates waste in the respective designated areas Weights ingredients to be used in the manufacturing of product, including activities related to active ingredients like sieving, subdivision and intermediate formulation Complies with standard operating procedures, batch records, production records, sheets, checklist and process related documentation Supports in other quality related activities such as product evaluation, statistical sampling, microbiological sampling using aseptic techniques, and others as required Alerts and informs the supervisor and group leader about any incident that could represent a risk or hazard for anyone or for the manufacturing process.

Removes material and product between batches according to procedures to avoid mix-ups or contamination Alerts the supervisor about any potential safety hazard or contamination risk Participates in continuous improvement initiatives related, but not limited, to cost reduction, process optimization, quality level improvement, output increase Performs material transactions on the inventory system Follows site general procedures and policies. Uses the personal protective equipment PPE required for the process or task to be performed.

Informs any deviation or potential deviation to the supervisor Takes action as per procedures to avoid or minimize impact to the process or operations Segregates waste dangerous, non-dangerous according to procedures and guidelines. Maintain and verify drug inventory controls are at a level to meet customer demand. Participate in drug inventories. Procurement responsibilities include providing information, guidelines and collaboration to facilitate the procurement process.

Policies and procedures are continuously reviewed and revised to ensure our company remains efficient and competitive. Candidates must be enrolled in an accredited college throughout the duration of the internship. Minimum 3. Responsible for designing and managing formulation development projects leading to clinical evaluation of drug delivery systems for HIV prevention and contraceptive products Interact with contract labs to maintain scientific quality and timeline management Responsible for writing and editing portions of regulatory documents including Quality CMC sections of INDs, IDEs, and annual reports Assist in the development of new concept papers, grant proposals and other funding initiatives Responsible for preparing written and oral presentations and reports to enable dissemination of project plans and results to stakeholders and the greater scientific community Assist with specific drug development activities e.

Share actively learnings with the global team providing input and guidance on business and market strategies Identify and support new packaging opportunities and defend business at risk. Gather quantifiable information as to size, timing and probability as well as about the specific value chain and product specifications.

A Bachelor Degree is required Ideally several years of experience in the Medical or Pharmaceutical Industry or the related value chain Being at ease when dealing with people. Showing strong talent to negotiate, to influence and to listen carefully.

Exhibit excellent mechanical aptitude Demonstrate good interpersonal, communication, and presentation skills Sucessfully handle multiple projects to achieve company objectives Exhibit competency in use of common computer software packages Demonstrate ability to work within a project plan Must have a four-year degree in chemistry, chemical engineering, pharmacy, or related discipline Must be eligible to work in the US Students pursuing master or Ph.

SAMPLE RESUME FOR FITTER MACHINIST

Experienced in supporting a very wide portfolio of both pharmaceutical products and medical devices for prominently the Australian and New Zealand market. Track record of achieving exceptional results in supporting the launch of new products to market and in the life-cycle management of on-market products. Victoria Ramirez. Professional Summary. Experienced in the preparation and registration of new products,including both sterile injectable generic pharmaceuticals and medical devices including consumables, electronic devices and software devices.

Experienced in liaising with TGA and Medsafe regulatory authorities for both pharmaceuticals and medical devices. Sound understanding of regulations, standards and legislation for Australia and New Zealand therapeutic products. Ability to work in a high pressured environment to meet stringent regulatory and corporate timelines. Extensive attention to detail and excellent written and communication skills Great track record of cross-functional collaborations with stakeholders internal and external to the business.

Represent regulatory in cross-functional collaborations with stakeholders internal and external to the business. Product Stewardship Product Safety Classify chemicals per regulatory requirements Assist with development of standard operating procedures and work rules Assist with continuous process improvement for safety data sheet authoring process 5 years of relevant experience required Familiarity with SDS authority software, WERCs Familiarity with consumer goods manufacturing processes and safety issues Strong undergraduate coursework in Chemistry, including Inorganic Chemistry, Organic Chemistry and Calculus Product Stewardship and Product Safety professional experience Willing to accommodate local travel to meet with clients Masters degree preferred Previous employment with or involving a consumer goods manufacturing company i.

Drives the execution of said documents Monitor and submit applicable reports and responses to regulatory authorities Maintain annual licenses, registrations and listings Ensure compliance with product post-marketing approval requirements Review and approve required reports, supplemental submissions and other post marketing commitments Evaluate post-market incident reports and determine MDR requirements.

Report adverse events to internal stakeholders Prepare and facilitate collection of necessary information for post-market health hazard evaluations, recall evaluations, MDR evaluations Provide regulatory input for UDI compliance requirements Minimum Education - Bachelor's degree in science biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology ; math; engineering; or medical fields is preferred Certification is a plus such as RAC from the Regulatory Affairs Professionals Society.

Combination product experience preferred Must have experience with US and European medical device submissions, regulations, and standards Must have directly authored k s and have experience in preparing other regulatory documents i.

Cross-functional experience preferred Demonstrated ability to provide guidance and mentoring to less experienced colleagues and cross-functional team members. Lead changes to the systems where required Lead divisional improvement activities and transactional LEAN projects. Prepare required documentation as needed e. Medical writing Advertising and promotion Labeling Controlled substances e.

DEA Restricted substances e. Provide regulatory support and guidance to local and global internal networks Prepare and coordinate regulatory submissions for licensing and health authority engagement; prepare responses to health authority requests and apply valid scientific rationale to facilitate regulatory approvals and positive assessments. An advanced degree or post-graduate Diploma or Certificate from a Regulatory Affairs program are assets Minimum 3 years of experience in Regulatory Affairs in regulated health products, food and beverage or CPG regulations.

This position requires a significant amount of initiative and judgment While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to use a computer, and communicate with peers and co-workers. Prepare regulatory submissions assuring that submissions are accurate, submitted on time, and gain approvals as scheduled Specific ability to file New drug applications NDA with clinical investigation requirements and abbreviated new drug applications ANDA Specific ability to file drug master files for active pharmaceutical ingredients Files supplements and annual reports as required for all active drug and medical device approved and pending applications Evaluates new product proposals presented by customers to assure that the product can be produced in a regulatory compliant manner Maintain organization of regulatory files to assure accurate responses to agency requests and maintenance of medical device design history files Maintain expertise regarding current and developing U.

Assist in developing regulatory strategies for the development and registration of medical devices and in vitro diagnostic kits Support preparation of complex submissions to gain approvals for clinical research and commercial distribution, such as: IDE, ITA, k , PMA, Design Dossier, Technical File, and Canadian Applications Manage assembly and submission of applications to regulatory bodies including FDA, Health Canada, and Notified Bodies Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations Evaluate documentation for clinical research and pre-market applications such as protocols, reports, scientific documents, labeling, risk documents, biocompatibility, ER checklists, clinical evaluations, etc.

Candidate can expect to spend a couple of days per month at our Newtown, PA office. Clinical study or epidemiology experience preferred Entry level accepted, years regulatory experience preferred Good written and oral English communication skills Good Computer skills: Outlook, Excel, Power Point Conscientious. Desirable experience in Medical Devices, Pharma background is acceptable. Professional certification s preferred Demonstrated success in management of regulatory submissions activities Thorough understanding of global regulations Strong technical knowledge of medical products Strong technical understanding of relevant procedures, practices, and associated medical terminology Strong knowledge of clinical trial strategy and study design, and sponsor reporting requirements Thorough knowledge of product development process and design control Excellent research and analytical skills Ability to effectively manage multiple projects Excellent written and oral communication, technical writing and editing skills Strong leadership, interpersonal and influencing skills.

Develop regulatory strategies for the development and registration of medical devices and in vitro diagnostic kits Prepare complex submissions to gain approvals for clinical research and commercial distribution, such as: IDE, ITA, k , PMA, Design Dossier, Technical File, and Canadian Applications Manages assembly and submission of applications to regulatory bodies including FDA, Health Canada, and Notified Bodies Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations Evaluate documentation for clinical research and pre-market applications such as protocols, reports, scientific documents, labeling, risk documents, biocompatibility, ER checklists, clinical evaluations, etc.

Handles and supervises product registration administration processes Updates the company on new regulations and procedures Maintenance of corporate databases Clinical Trial Application. Apply the Regulatory Foundation Must be a results-oriented team player capable of working in a fast paced environment with changing priorities Must be a self-starter able to work with minimal supervision, and able to perform under pressure and in ambiguous situations Must be organized and detail-oriented, with good analytical and decision making skills Must demonstrate effective verbal and written communications skills.

International regulatory medical device experience is a plus Strong decision making skills in ambiguous or unclear situations Demonstrated attention to detail and organizational skills Capable of effectively managing multiple projects with shifting priorities Ability to identify compliance risks and escalate when necessary Technical system skills e. Position provides regulatory support for the Smiths Medical site based in St. Paul, Minnesota. Incumbent develop and prepare regulatory submissions, i.

This individual proactively evaluates existing and emerging regulatory and quality requirements and directs implementation activities to minimize business exposure and guidance for interactions with government officials. This position is responsible for practicing Quality System Manual procedures and complying with its requirements, and carrying out responsibilities as outlined in safety, health and environmental policies Develop and prepare regulatory plans, submissions; specifically k Premarket Notification, PMA, IDE, Design Dossier, Technical Files, Australian Technical Files, Canadian Licensing, and Japan submissions.

Coordination of staff support for world-wide registrations for global growth and expansion Review and ensure regulatory compliance of internal operational and project documentation involved in commercial product release for all assigned projects. Prepare, maintain and ensure regulatory documentation supporting engineering activity is filed and readily available, keeping electronic lists, registers and directories up-to-date Participate as regulatory representative on project teams, communicate regulatory requirements and strategy.

Assist with data entry and analysis as needed, ensuring data quality and validity. Participate as Regulatory Representative on project teams Bachelor's degree in Science or Engineering or related field from an accredited college or university required. Ability to manage multiple projects and proficiency with Microsoft Office and software tools Ability to analytically assimilate regulatory information and updates and effectively convey these principles to appropriate cross functional departments and levels of management Ability to critically analyze information as it relates to regulatory submissions and clinical protocols Excellent verbal, written, and presentation communication skills.

Job title: Associate Regulatory Affairs Specialist Reporting to: Regulatory Affairs Manager Functional group: Market Access Ensures compliance with regulatory agency regulations and interpretations Prepares responses to regulatory agencies' questions and other correspondence Organizes and maintains reporting schedules for new drug application and investigational new drug Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides Provides solutions to a variety of problems of moderate scope of complexity Conducts searches of existing files for requested information Maintains and archives all regulatory documentation Bachelor Degree or above Minimum 2 years solid and reputable experience in regulatory affairs Proficiency in both spoken and written English and Chinese Essential — Market Knowledge Business Relationship Regulatory Environment Reimbursement Important — Ability to manage multiple projectsW.

Develops proficiency in any applicable regulatory requirement that applies to our products and ensures new or changed requirements are communicated within the organization Provides support to tender and importation requests in case of necessary regulatory documentation Follow up on Quality Requests, as assigned by the Regulatory Affairs Manager Ensure full alignment in all activities with relevant department process and company SOP i.

Track and report regulatory project status and informational documents appropriately Maintain submission correspondence files and other regulatory files in a complete and secure manner for regulatory and quality compliance. French is plus 1 - 2 years of administrative experience Computer literate. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies Prepare FDA submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release Provide support to currently-marketed products as necessary.

This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status. Provide on-going expertise to teams for regulatory issues and questions Provide comprehensive product information to worldwide peers for product introductions and training.

Review advertising, promotion and training materials. Provide support to currently marketed products as necessary. All significant issues will be reviewed by the manager Regularly communicates with senior management and regulatory agencies. Influence and inspire alignment with business goals, internally and externally Apply extensive technical or regulatory principles, theories and concepts and has full knowledge of other related disciplines Develop strategies that leverage opportunities and experiences across functions Develop technical solutions to complex problems that require the regular use of ingenuity and creativity.

Expert problem solving skills and experience with complex issues that require resolution. Ability to work independently and make decisions that have significant impact to the company. Acts on own initiative to identify opportunities and propose solutions outside the scope of their job responsibility. Strong interpersonal skills Demonstrated ability to define problems and provide guidance to management in developing and implementing solutions Analytical and creative thinking skills and the ability to solve complex problems Or-.

Related Job Titles. Regulatory Affairs Analyst Resume Sample. Regulatory Compliance Specialist Resume Sample. Regulatory Affairs Manager Resume Sample.

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