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regulatory affairs in Newark

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  1. Senior Associate Regulatory Affairs at Alvogen

    The Senior Associate, Regulatory Affairs reports into the Manager, Regulatory Affairs and is based in Pine Brook, New Jersey....

  2. Sr. Publisher – Regulatory Affairs at Cognizant

     Compilation of regulatory documents, Maintaining Regulatory documents as per the procedure in client repository....

  3. 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);...

  4. Senior Associate, Regulatory Affairs at Par Pharmaceutical an Endo International Company

    3 – 5 years experience in regulatory affairs. The Senior Associate, Regulatory is responsible for performing all regulatory functions and supporting all efforts...

  5. Senior Associate, Regulatory Affairs Operations at Par Pharmaceutical an Endo International Company

    Regulatory & FDA Guidance. § A minimum of 2 years’ general regulatory affairs experience preferably with a focus on electronic submissions....

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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. Manager, Regulatory Affairs at Par Pharmaceutical an Endo International Company

      Manager, Regulatory Affairs - Submissions. 5 – 8 years experience in regulatory affairs. Conduct regulatory due diligence for internal and/or external R&D...

    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. 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...

    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. Director/Senior Director, Medical Information (Palo Alto, CA or Philadelphia, PA) at Jazz Pharmaceuticals

      Ability to collaborate with internal colleagues in clinical, regulatory, drug safety, and medical affairs, and other departments as required....

    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/AD, Medical Science Liaison - CV/Met (Upstate NY, CT, VT) at Boehringer Ingelheim

      Compliance and other regulatory and/or organizational requirements:. Experience leading field based medicine or medical affairs projects, or mentoring MSLs –...

    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. Senior Manager Regulatory Affairs Topical Pain RX to OTC switch at Robsco Search

      8 year experience within Regulatory Affairs. Our client currently have a Category Regulatory Affairs Senior Manager vacancy within our global Pain category...

    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. Sr Manager, Regulatory Affairs - Rx to OTC Switch at GlaxoSmithKline

      8 year experience within Regulatory Affairs. Understands the global regulatory environment related to self-care, actively monitors the changing regulatory...

    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. Counsel to Equities Division (AVP/VP) at Deutsche Bank

      Legal, Compliance and Government & Regulatory Affairs. Our Legal, Compliance and Government & Regulatory Affairs department manages the legal services, reviews...

    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. 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. Sr. Revenue Analyst at NRG Energy

      Work closely with the power trading desks, regulatory affairs personnel, and FERC legal counsel in reconciling internal and external financial settlement...

    1. 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...

      1. Enhanced Due Diligence Officer at

        Advanced degree in law or international political affairs preferred Advanced understanding of international economics and/or political affairs ACAMS certified...

      2. Senior Medical Director – Medical Safety Evaluation - Temp to Perm at Mitsubishi Tanabe Pharma America

        Interacts extensively with international affiliates and MTPC corporate to provide medical/drug safety input to clinical research (scientific and operational),...

      3. Pharmacy Technican at St. Joseph's Healthcare System

        Assists OR/Anesthesia staff with meeting regulatory compliance (DNV, NJ Board Division of Consumer Affairs, DEA, etc.)....

      4. Pharmacy Technician at St. Joseph's Healthcare System

        Assists OR/Anesthesia staff with meeting regulatory compliance (DNV, NJ Board Division of Consumer Affairs, DEA, etc.)....

      5. Director, Clinical Studies at PixarBio Corporation

        Coordinate with Regulatory Affairs to determine and meet FDA guidelines and submission requirements. Leading society’s mandate for non-opiate and non-addictive...