• GRA Device Lead (Director)

    Sanofi Group (Morristown, NJ)
    **Job Title:** GRA Device Lead (Director) **Location** : Morristown, NJ, Cambridge, MA, Framingham, MA **About the Job** Are you ready to shape the future of ... function is comprised of more than 1800 people. The GRA Device Lead for Specialty Care Combination...contributor on assigned projects. The role will represent the GRA Device perspective as a member of project… more
    Sanofi Group (07/15/25)
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  • Senior Director, Global Regulatory Affairs…

    Takeda Pharmaceuticals (Lexington, MA)
    …controls, deviations, and investigations. + Masterfully lead within a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA ... execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA CMC Product Lead and/or team lead . Assigned… more
    Takeda Pharmaceuticals (07/30/25)
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  • Senior Director, Global Regulatory Affairs…

    Lilly (Indianapolis, IN)
    …Applications, post-approval supplements/ variations and responses to questions. **Oversight of CMC Project Deliverables** + Ensures appropriate definition and ... **Purpose:** The Senior Director of Global Regulatory Affairs - CMC ( GRA - CMC ) leads and manages...external environment. + Utilizes scientific and regulatory knowledge to lead preparation, review, and finalization of CMC … more
    Lilly (06/25/25)
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  • Associate Director, Global Regulatory Affairs,…

    Takeda Pharmaceuticals (Boston, MA)
    …to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director, GRA CMC Small Molecules where you will oversee the development and ... CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products… more
    Takeda Pharmaceuticals (07/08/25)
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  • Director, CMC Regulatory Affairs Biologics…

    J&J Family of Companies (Horsham, PA)
    …the execution of key projects and workstreams. + Lead initiatives within CMC Regulatory Affairs (RA)/Global Regulatory Affairs ( GRA ) for the Biologics New ... located in Horsham, PA; Spring House, PA; Titusville, NJ; or Raritan, NJ. The Director, CMC Regulatory Affairs Biologics New Modalities will lead a team of … more
    J&J Family of Companies (08/01/25)
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  • Senior Manager, Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. (Bismarck, ND)
    …- Serves as the sponsor point of contact to the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to ... activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global requirements and provides an assessment of the… more
    Otsuka America Pharmaceutical Inc. (06/19/25)
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