• Small Molecules Regulatory Affairs

    Gilead Sciences, Inc. (Foster City, CA)
    …Join Gilead and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible ... + MD **Preferred Qualifications** + Has 5+ years of relevant experience in Regulatory Affairs CMC or other relevant industry experience with advanced degree.… more
    Gilead Sciences, Inc. (04/15/25)
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  • Associate Director, Regulatory

    Gilead Sciences, Inc. (Foster City, CA)
    …and help create possible, together. **Job Description** We are seeking an Associate Director, Regulatory Affairs CMC candidate to sit at our Foster City, ... CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing strategic direction, operational… more
    Gilead Sciences, Inc. (02/07/25)
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  • Advisor/Senior Advisor Global Regulatory

    Lilly (Indianapolis, IN)
    …patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC ... life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to… more
    Lilly (04/22/25)
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  • Senior Director, Global Regulatory

    Lilly (Indianapolis, IN)
    …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the ... scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities… more
    Lilly (03/26/25)
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  • Regulatory Affairs CMC

    Amgen (New Albany, OH)
    The Regulatory Affairs CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for ... manufacturing, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry + Regulatory CMC experience + Ability to develop solutions to… more
    Amgen (02/23/25)
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  • Director, Global Regulatory Affairs

    Lilly (Indianapolis, IN)
    …for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the… more
    Lilly (02/15/25)
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  • Senior Manager, Regulatory Affairs

    AbbVie (North Chicago, IL)
    …and company policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product ... department. Participates in initiatives internal to RA CMC . Represents CMC regulatory affairs on project initiatives with other functional areas to… more
    AbbVie (04/29/25)
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  • Manager, Regulatory Affairs

    AbbVie (North Chicago, IL)
    …supervision. Analyzes and approves manufacturing change requests with limited supervision. + Represents CMC regulatory affairs on teams such as the product ... Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls ( CMC ) works with internal… more
    AbbVie (05/03/25)
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  • Director, CMC Regulatory

    Gilead Sciences, Inc. (Foster City, CA)
    …and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible ... of an approved/ harmonized regulatory control strategy. + Partner across CMC Regulatory Affairs , PDM, and other functional groups across Gilead. + Lead… more
    Gilead Sciences, Inc. (05/03/25)
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  • AD / Sr AD, US Product CMC

    Boehringer Ingelheim (Ridgefield, CT)
    …strength and competitive advantage lie with our people. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and ... and post marketing reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for all US … more
    Boehringer Ingelheim (03/04/25)
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