• Head of CMC Regulatory Affairs…

    Gilead Sciences, Inc. (Foster City, CA)
    …with any broader initiatives in this space across the enterprise. + Lead workforce capability design, training strategy , and upskilling initiatives. ... Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives. + Experience with CMC requirements for drug… more
    Gilead Sciences, Inc. (11/19/25)
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  • Director, Global Regulatory Affairs…

    Takeda Pharmaceuticals (Boston, MA)
    …contribute:** + Develops, executes and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy . + Guide the team to define ... and drive strategy for CMC regulatory dossier...Team lead role, prepares and maintains relevant regulatory documentation (eg, technical regulatory strategy… more
    Takeda Pharmaceuticals (12/24/25)
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  • Director, Regulatory Affairs CMC

    Taiho Oncology (Princeton, NJ)
    …CMC ) documentation for regulatory filings. + Experience in developing and implementing CMC regulatory strategy for early and late stage of development ... expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director,...will play a pivotal and visible role in advancing CMC strategy and submissions of developmental, life… more
    Taiho Oncology (12/09/25)
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  • Associate Director, Regulatory CMC…

    BeOne Medicines (Emeryville, CA)
    …**Essential Functions of the job:** + Lead , develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for ... project + Work collaboratively with cross-functional leads and communicates CMC regulatory strategies for the assigned projects. + Lead regulatory … more
    BeOne Medicines (12/23/25)
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  • Head of Global Regulatory Affairs,…

    Sanofi Group (Morristown, NJ)
    …that model the Sanofi and GRA Values/Principles/Competencies. + Oversees the development of CMC regulatory strategy and regulatory risk assessments ... landscapes. With a commitment to Sanofi's "Take the Lead " values, particularly in "Leading Together" and "Being Bold,"...with FDA and EMA, so that appropriate and pragmatic Regulatory CMC positions are negotiated with the… more
    Sanofi Group (12/22/25)
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  • Director, Regulatory Site CMC

    Takeda Pharmaceuticals (Boston, MA)
    …requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market ... Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and...rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities… more
    Takeda Pharmaceuticals (12/10/25)
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  • Global Manufacturing Sciences CMC…

    Takeda Pharmaceuticals (Lexington, MA)
    …manufacturing, quality, and regulatory frameworks, and how to apply these in CMC strategy and execution. + Demonstrated ability to lead complex, ... the role** Join us as our **Global Manufacturing Sciences CMC Lead ** and drive **high-impact, high-visibility ...global product and governance teams, driving clear decisions on CMC strategy , lifecycle management and technology excellence.… more
    Takeda Pharmaceuticals (12/04/25)
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  • Director CMC Regulatory Affairs

    Regeneron Pharmaceuticals (Troy, NY)
    …with the Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies and ... clinical registrations, market application approvals, and post-approval lifecycle management. + Lead the preparation, review, and submission of regulatory … more
    Regeneron Pharmaceuticals (12/20/25)
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  • GRA CMC Lead

    Sanofi Group (Framingham, MA)
    …worldwide. Ready to get started? Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the opportunity to ... + _Location: Morristown, NJ_ **About the Job** As GRA CMC Lead within our GRA CMC...drive regulatory strategy for pharmaceutical products and vaccines across their lifecycle.… more
    Sanofi Group (01/14/26)
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  • Director, Scientific Expert CMC

    Boehringer Ingelheim (Athens, GA)
    …small molecule and biologic drug development, analytical chemistry, formulation science, and regulatory CMC strategy . + Adept at integrating scientific ... regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls ( CMC...vaccine products. The incumbent may serve as a Global Regulatory Project Lead within the project core… more
    Boehringer Ingelheim (12/12/25)
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