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  1. Regulatory Affairs Associate II – PharmaCMC at Fresenius Medical Care

    With some senior team member or management oversight, collects and coordinates information to prepare regulatory documentation packages for review and...

  2. Sr RA Associate Ops at Fresenius Medical Care

    Coordinates with regulatory staff to compile regulatory submissions. Responsible for assisting in the support of the daily operational activities within...

  3. PV Benefit Risk Physician – Vaccine Business Unit at Takeda Pharmaceuticals

    Proven collaborative internal relations with Clinical Development, Regulatory Affairs, Medical Affairs, Quality and Legal Counsel....

  4. Principle Regulatory Affairs Associate Operations at Fresenius Medical Care

    Coordinates with regulatory staff to compile regulatory submissions. Responsible for supporting the daily operational activities within Regulatory Affairs for...

  5. Director, Regulatory Affairs at PixarBio Corporation

    PixarBio seeks a qualified, highly motivated individual to serve as Director, Regulatory Affairs to implement the company’s regulatory strategies for all...

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    1. Senior Compliance & Regularoty Affairs Specialist

      At Boston Children's Hospital, success is measured in patients treated, parents comforted and teams taught. It's in discoveries made, processes perfected, and technology advanced. In major medical breakthroughs and small acts of kindness. And in colleagues who have your back and patients who have your heart. As a teaching hospital of Harvard Medical School, our reach is global and our impact ...

    2. Senior Investigator I, Biologics PK/PD

      Job Description: Job Purpose• Representation of LF on cross-functional Project Teams (NIBR and Development) involved in the development of Biologics drugs• Negotiate an optimal nonclinical and clinical PK/PD strategy in liaison with appropriate line functions and with Management input as appropriate. • Responsible for the PK and PK/PD component of nonclinical and clinical protocols, reports, ...

    3. Global Regulatory Affairs Director

      Director Level | Regulatory Affairs | Cross-Therapeutic Location: New Jersey, Boston, San Francisco, Austin, Denver, Chicago, Cincinnati, Raleigh Salary: $140,000 - $300,000 + bonus + excellent benefits + relocationOne of the world’s largest biopharmaceutical and medical device companies is looking to add to its already growing domestic presence.  Due to a strategic realignment the company ...

    4. Program Manager - GEMS

      Program Manager, Genetically Engineered Models & Services (GEMS) Boston, MA areaBASIC SUMMARY:Responsible for coordinating complex programs and provide consultation on business and scientific issues across the GEMS organization. Provide independent program management and serve as genetic testing subject matter expert. Serve as a single point of contact as a scientific liaison between the BBO ...

    5. Biotechnology/Science Recruiter / Search Consultant - Cambridge, MA

      Are you someone who craves a position that will pay you for your talents, rather than your tenure? Are you competitive? Do your friends tell you that they think you have ADD and/or are you someone who loves to juggle many things at once? If so, you may be the perfect next HireMinds Search Consultant! By joining a firm that has been around for over 18 years, you will be surrounded by ...

    6. Senior Manager Quality Systems Medical Devices or Pharma

      PURPOSE AND SCOPE: Supports FMCNA's mission, vision, core values and customer service philosophy. Adheres to all FMCNA Compliance Programs, including following all regulatory and FMCNA policy requirements. Provide leadership, guidance and support for all QS, Quality Engineering (QE) activities in FMCNA, as well as assist in conducting analysis and investigations of product or quality ...

    7. CMC Project Manager

      An expanding pharmaceutical company in Lexington, MA has an immediate need for a CMC Regulatory Affairs Project Manager.DESCRIPTION: Knowledge of global CMC regulatory submission requirements: including submission formats eCTD for IND, IMPD, NDA, MAAs and NEES. Department lead on the clinical and commercial CMC submission processes. Tracking global submission activities. Oversees regulatory ...

    8. Director - Clinical Affairs - Companion Diagnostics - Cambridge, MA

      Fast growing biotech company working on highly specialized products in the oncology field seeking individual with ability to directly oversee clinical trial programs for companion diagnostic products. Activities: *** Develop clinical trial plans for predictive, prognostic and diagnostic tests incorporating requirements from doctors, regulatory agencies and payor groups. *** Execute ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    9. Quality Engineer

      Opportunity: Located in our Mansfield, MA facility, the Quality Engineer shall support the facility and departments in the development, implementation and maintenance of the quality system. Division Information: Teleflex Medical OEM is the leading, global provider of comprehensive product development and production services to medical device manufacturers across the world. We set ourselves ...

    10. Program – Clinical Trial Coordinator

        The Program Clinical Trial Coordinator (P-CTC) provides daily, direct support to the Director of Global Clinical Operations and Clinical Development Team Lead to drive efficiency and consistency across programs.  He or she has the responsibility to support the project team to achieve quality results in a cost-effective timely manner. In doing this, the P-CTC represents inVentiv Health ...

    11. Product Safety Review Consultant - Pharmacovigilance

        Cambridge, MA Product Safety Review Consultant Contract - BHCJP00013769/BHCJP00013739 W-2 ONLY  DESCRIPTION This role is responsible for aggregate review and reporting of safety data from various sources in support of regulatory aggregate reporting requirements, as well as safety surveillance and risk management activities pertaining to products. RESPONSIBILITIES Summarize safety ...

    12. Associate Medical Director

      A Drug Safety Associate (DSA), known also in the industry as a Pharmacovigilance Officer, is a health science professional responsible for the monitoring, data collection and analysis, and reporting of drug safety information for compliance with drug safety regulations in the U.S. and international markets.   Cambridge, MA Associate Medical Director Contract - BHCJP00013871 W-2 ONLY ...

    13. CMC Project Manager

      An expanding pharmaceutical company in Lexington, MA has an immediate need for a CMC Regulatory Affairs Project Manager.DESCRIPTION: Knowledge of global CMC regulatory submission requirements: including submission formats eCTD for IND, IMPD, NDA, MAAs and NEES. Department lead on the clinical and commercial CMC submission processes. Tracking global submission activities. Oversees regulatory ...

    14. Program Manager - GEMS

      Program Manager, Genetically Engineered Models & Services (GEMS) Boston, MA area BASIC SUMMARY: Responsible for coordinating complex programs and provide consultation on business and scientific issues across the GEMS organization. Provide independent program management and serve as genetic testing subject matter expert. Serve as a single point of contact as a scientific liaison between the ...

    15. Global Medical Director-Biopharm with Multi-Billion Dollar Investment

        Global Medical Director Needed for US Biopharmaceutical Company with Recent Multi-Billion Dollar Investment Global Medical Affairs Strategy Clinical Development Phase III & IV Trial Management Oncology Immunology Neurology   Executive Director Level | Regulatory Affairs | Cross-Therapeutic Location: Boston Salary: $275,000 - $350,000 + bonus + excellent benefits + ...

    16. Scientist - Greater Boston

      Job Description: The ideal candidate for the Scientist role will be responsible for the development, optimization and qualification of robust invitro bioassays in house suitable for the characterization of biological potency of therapeutic biologics or small molecule drug candidates. She/he will serve as tech lead and SME to transfer the optimized bioassays to CROs for further phase ...

    17. Consumer Marketing (Associate/Director)

        Top globally recognized pharmaceutical company Location: Near Somerville, MA (Cambridge, MA) Compensation: $100 - $140K Position Background: The incumbent will develop and execute innovative strategies related to marketing and awareness. Must be able to create a best-in-class experience for all stakeholders, most importantly for people living with MS. Roles & Responsibilities: ...

    18. CMC Project Manager

      An expanding pharmaceutical company in Lexington, MA has an immediate need for a CMC Regulatory Affairs Project Manager.DESCRIPTION: Knowledge of global CMC regulatory submission requirements: including submission formats eCTD for IND, IMPD, NDA, MAAs and NEES. Department lead on the clinical and commercial CMC submission processes. Tracking global submission activities. Oversees regulatory ...

    19. Manufacturing Engineer

      Opportunity: The Manufacturing Engineer is responsible for supporting manufacturing, providing production guidance to manufacturing employees, designing and developing extrusion processes and products; this is a hands-on position which will provide key technical support throughout the Operation. This person will also take a leadership role in manufacturing and engineering functions such as ...

    20. QUALITY ASSURANCE - ASSISTANT DIRECTOR - COMBINATION PRODUCTS

      (Need 2 of these people) QUALITY ASSURANCE - ASSISTANT DIRECTOR, COMBINATION PRODUCT Chicago, Il FULL RELO DESCRIPTION The R&D GMP Quality, Clinical Product Supplies, organization is responsible for Product Quality Assurance for investigational medicinal products (IMP), including both pharmaceutical drug and drug/device combination products. These activities comprise of disposition ...

    21. Product Safety Review Consultant (3654)

      This role is responsible for aggregate review and reporting of safety data from various sources in support of regulatory aggregate reporting requirements, as well as safety surveillance and risk management activities pertaining to client products. • Must have authored Safety/Regulatory documents such as PBRER’s, DSUR’S, PRAC Response, Regulatory submission, RMP Plans, Company Core Safety ...

    22. Clinical Research Manager

      Publcily TRaded Top Tier Global Pharmaceutical Company is looking for a Clinical Research Manager (early phase) professional to be located in their Cambridge, MA Headquarters Contract (w-2) is for one year and can be renewed or go perm (FTE)  Duties and Responsibilities:  • Manages the operational components of investigator initiated sponsored research, including the review, ...

    23. Evidence Evaluation Specialist

      The Evidence Evaluation Specialist (EES) is responsible for providing scientific support to both internal and external customers, including advisory boards, governing bodies, marketing, quality assurance, regulatory and clinical affairs, research and development, and legal. The SEA supports any core Scientific Affairs objectives. The EES works with other deparment personnel to develop and ...

    24. Director of CMC Regulatory Affairs

        Job Title: Director of CMC Regulatory Affairs             Leading pharmaceutical development company   Location: Boston, MA   Description: Provide regulatory direction and strategic technical input across all regulatory programs.   Responsibilities: Screen development of new requirements and inform senior management of impact to the company Give direction for regulatory ...

      1. Associate Director Global Marketing at Sanofi

        Collaborate effectively with Medical Affairs, Market Access, Regulatory Affairs, R&D and Marketing/Sales teams to support brand plan execution....

      2. Director Global Marketing Pompe at Genzyme

        Work closely with Regulatory Affairs and Corporate Affairs to build strong relationships with health authorities or regulatory bodies to identify customer needs...

      3. Director Pricing & Market Access and Health Economics Ixazomib at Takeda Pharmaceuticals

        These interfaces include but are not limited to the Commercial Leadership team, Global Regional, and Local Marketing, regional and local Market Access, US payer...

      4. Associate Vice President Regulatory Affairs at Genzyme

        The Associate Vice President, Regulatory Affairs, Therapeutic Area Head is part of the Genzyme Global Regulatory Affairs team based in US....

      5. AD Regulatory Affairs at Genzyme

        The Regulatory Affairs Associate Director is part of the Genzyme Global Regulatory Affairs team based in US....