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  1. Sr. Manager, Labeling & Promotional Review at LEO Pharma

    Direct experience in regulatory affairs is preferred. Manager, US Regulatory Affairs, Labeling & Promotional Review*. Regulatory, Clinical, etc);...

  2. Manager/Sr. Manager, Labeling, Advertising, & Promotional Review at LEO Pharma

    Direct experience in regulatory affairs is preferred. Regulatory, Clinical, etc); Manager, US Regulatory Affairs, Labeling, Advertising, & Promotional Review in...

  3. Principal Scientist, Analytical Services at Par Pharmaceutical an Endo International Company

    Interact with other departments, e.g. RA, Formulations, Regulatory Affairs, Production, Supply Chain, etc, to support timely new product development/submission...

  4. Clinical Data Standards Expert at Chiltern International

    Lead the collaboration between relevant functions (Clinical Operations, Clinical Science, Pharmacology, Data Management, Biostatistics, Regulatory Affairs,…) to...

  5. Account Executive at Tuv America

    TÜV SÜD Canada Inc., a global leader in product safety and EMC testing, regulatory affairs and certification, has immediate openings at our facility in Laval,...

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    1. Senior Manager - Biostatistics

      Global Pharmaceutical Company seeks a hands Senior Manager of Biostatistics to advise project teams on issues of study design, study endpoints, and statistical methods. He/she assures timely completion of the statistical methods section of protocols, sample size estimation, detailed statistical analysis plans, and statistical/clinical study reports for regulatory submissions and will oversee ...

    1. Clinical Data Standards Expert at Chiltern

      Lead the collaboration between relevant functions (Clinical Operations, Clinical Science, Pharmacology, Data Management, Biostatistics, Regulatory Affairs,…) to...

    1. Regulatory Affairs Specialist - medical device mfr

      Quality AssuranceRegulatory Affairs SpecialistREPORTS TOPRIMARY FUNCTIONQuality Assurance ManagerPrepare US and International regulatory filings and registrations. Ensure compliance with US and international regulations, standards and guidance. RESPONSIBILITIESPrepare FDA and international submissions for new products and product changes as required to ensure timely approval for market ...

    1. Compliance Sr Specialist at Cigna

      Acts as a liaison between the organization and regulatory agencies. Ideal candidate will be a self-starter with a willingness to learn new areas of the business...

    1. Head Oncology Medical Affairs

      Sandoz, a Novartis company, is a global leader in generic pharmaceuticals and biosimilars, driving access to high-quality healthcare. Sandoz employs more than 26,000 people worldwide and supplies a broad range of affordable medicines to customers around the globe. Our portfolio comprises approximately 1,100 molecules, which accounted for 2014 sales of USD 9.6 billion. Sandoz Inc is ...

    1. Senior Manager, Public Relations at PixarBio Corporation

      Coordinates Legal, Medical and Regulatory internal review process for materials developed. Potential litigation, product discontinuation and supply issues and...

    1. Project Physician/Medical Safety Officer

      Immediate Opportunity – Project Physician  My name is Alexis La Rosa and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a (an) Project Physician for our Fortune 500 client. This position is located in Titusville, NJ RELEVANT JOB HIGHLIGHTS/QUALIFICATIONSInvolved in the lifecycle management of a variety of marketed products across a diverse group of ...

    1. Labeling Operations Associate at Otsuka Pharmaceutical

      Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control....

    1. Regulatory Affairs Specialist - medical device mfr

      Quality AssuranceRegulatory Affairs SpecialistREPORTS TOPRIMARY FUNCTIONQuality Assurance ManagerPrepare US and International regulatory filings and registrations. Ensure compliance with US and international regulations, standards and guidance. RESPONSIBILITIESPrepare FDA and international submissions for new products and product changes as required to ensure timely approval for market ...

    1. Sr. Labeling Associate at Intuitive Technology Solultions

      Collaborates with Regulatory Affairs on submission and implementation strategy for labeling. Requires significant interaction outside the Regulatory Affairs...

    1. Regulatory Affairs

      Senior Associate, Regulatory Affairs*Management Positions also available for stronger applicants*SUMMARYIndependently authors, compiles, reviews and submits high-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Plans, coordinates and writes, clear, concise and accurate, responses to inquiries from FDA ...

    1. Medical Science Liaison/Sr. MSL Women's Cancer I/O - Northern CA/Reno, NV at AstraZeneca

      Adhere to internal standard processes and comply with regulatory and compliance requirements. The incumbent engages in scientific information exchanges with...

    1. Senior Safety Data Analyst

      Summary:Reporting to the Director of Informatics, this position will primarily deal with internal customers (e.g. PVRM physician’s), and act as the database ambassador of information. The individual will be responsible for contributing to external customer teams (e.g. Regulatory Affairs) in the compilation of Annual Reports.Essential Functions: Be able to create advanced level reports ...

    1. Associate Director, Medical and Scientific Writing, Regulatory Affairs (Palo Alto, CA or Philadelphia, PA) at Jazz Pharmaceuticals

      Experience with a variety of regulatory and clinical documents. Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents....

    1. Senior Safety Data Analyst (440633)

      OVERVIEW:Reporting to the Director of Informatics, this position will primarily deal with internal customers (e.g. PVRM physician’s), and act as the database ambassador of information. The individual will be responsible for contributing to external customer teams (e.g. Regulatory Affairs) in the compilation of Annual Reports.Essential Functions:Be able to create advanced level reports ...

    1. Clinical Affairs Specialist at Dako

      We are looking for a Clinical Affairs Specialist to join Medical & Clinical Affairs at Dako. As a Clinical Affairs Specialist your main responsibilities will be...

    1. Drug Safety Physician

      Vivos Professional Services is currently seeking candidates for a Pharmacovigilance Physician opportunity in Parsippany, New Jersey. Incumbent performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of the line listings of single cases and preparation of investigator ...

    1. Launch Readiness at Sanofi

      Knowledge of the regulatory landscape. In addition, the new recruit will have a good understanding of the regulatory, compliance and legal frame work....

    1. CMC Technical Writer (9182)

      About the Opportunity A pharmaceutical company in New Jersey is currently seeking a new CMC Technical Writer for a great opportunity with their growing staff. In this role, the CMC Technical Writer will be responsible for creating, compiling, and reviewing CMC regulatory documents and sections for ANDA and NDA submissions as well as other technical reports. Apply today!Company Description ...

    1. Associate Compliance Manager, Monitoring and Analytics at Allergan

      Provide support during regulatory inspections and investigations. Sales and marketing activity, grants, sponsorships, medical education, off-label promotion,...

    1. Reg Affairs Lead Biologics

      Accountable for the development of innovative regulatory strategiesLead activities, including planning and reviewing sections of all regulatory submissions to support clinical trials and product registration     Serve as the Regulatory Affairs lead representative on the Development TeamLead the development  of the U.S. portion of the Regulatory PlanAssist as the US regulatory representative ...

    2. Quality Assurance Manager

      Due to unprecedented growth our client a generic pharmaceutical company located in New Jersey currently has approval to add to its staff a Manager of Quality Assurance.JOB SUMMARY:The Manager of Quality Assurance provides for the development and implementation of computerized and other processes that will assure that primary documentation systems encompassing records mandated to comply with ...

    3. Senior Manager of Regulatory  Manager

      Senior Manager of Regulatory  ManagerThe Senior Regulatory Affairs Manager will independently prepare, review and submit high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws.Primary Responsibilities :Author and prepare original ANDA’s/NDA’s amendments in electronic format for submission to the ...

    4. Pharmacovigilance/Drug Saftey Leader

      Hello, We are looking for an experienced and qualified candidate for a Drug Safety Lead Role for a Global Pharma Client.Education:MD REQUIRED (Foreign MD will also be considered)Duties:Performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of the line listings of ...

    5. Manager of Regulatory Affairs 363.16JF

      :: If you meet the qualifications listed below and would like more information contact Jeff at 815-756-1221 Attach resume when responding to this posting :: The Manager of Regulatory Affairs will be responsible for maintaining compliance to internal standards and applicable regulations for all products, interpreting labeling regulations and guidance that applies to labeling to best represent ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    6. Medical Device RA/QA Consultants and Trainers - Any location

      Oriel STAT A MATRIX provides consulting and training support to medical device manufacturers around the world. Our team of consultants/trainers is comprised of both full-time employees and independent consultants (the latter of whom we call affiliate consultants). By using a combination of employees and affiliate consultants, we maintain a robust consulting team. This allows us to provide a ...

    7. Clinical Manager (440180)

      OVERVIEW:Provides leadership and day-to-day guidance to internal and External Service Provider (ESP) study team for all protocols within an assigned program. Ensures cross-study consistency in protocol design, data analysis and reporting. Interacts with expert physicians, investigators, ESP personnel, and functional area staff to ensure program strategy and objectives are understood and ...

    8. Clinical Trial Manager

      Vivos Professional Services is currently seeking candidates for a Clinical Trial Manager position. The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level for assigned clinical projects. The CTM leads internal cross-functional teams and manages the Sponsor relationship with vendors and CROs to ensure ...

    9. Regulatory Affairs Manager (8184)

      About the Opportunity A recognized pharmaceutical company headquartered in New Providence, NJ is actively seeking a diligent and self-motivated individual for a promising opportunity on their staff as a Regulatory Affairs Manager. In this role, the Regulatory Affairs Manager will compile, review, submit, and manage eCTD submissions to the FDA. Additionally, the Manager will assist in ...

    10. Regulatory Affairs Specialist - medical device mfr

      Quality AssuranceRegulatory Affairs SpecialistREPORTS TOPRIMARY FUNCTIONQuality Assurance ManagerPrepare US and International regulatory filings and registrations. Ensure compliance with US and international regulations, standards and guidance. RESPONSIBILITIESPrepare FDA and international submissions for new products and product changes as required to ensure timely approval for market ...

      1. Director, Global Labeling at Fairway Consulting Group

        The Director, Global Labeling is responsible for the leadership and oversight of the Labeling function within Global Regulatory Affairs (GRA)....

      2. Associate Director, Global Labeling at Fairway Consulting Group

        The Associate Director, Global Labeling will provide leadership to the Global Regulatory Affairs Labeling Group, within Commercial Regulatory Affairs, by...

      3. Product Manager at Par Pharmaceutical an Endo International Company

        Partners with internal teams (such as Regulatory, Medical Affairs, National Accounts, Customer Service, Supply Chain) to develop field communications, marketing...

      4. STARLIMS SME/Developer and Configuration Specialist at LabAnswer

        The LIMS SME/Developer and Configuration Specialist will provide product knowledge for installing and configuring StarLIMS LIMS/ELN systems for Food and Drug...

      5. Instructor/Assistant Professor at Rutgers University School of Health Professions

        Life Science, Clinical Research, Regulatory Affairs, Medical Affairs:. (1) a minimum of a PhD degree in Life Science/Health/Biomedical Informatics, or in a...