• Director , CMC Regulatory…

    Gilead Sciences, Inc. (Foster City, CA)
    …and inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics ... of an approved/ harmonized regulatory control strategy. + Partner across CMC Regulatory Affairs , PDM, and other functional groups across Gilead. + Lead… more
    Gilead Sciences, Inc. (08/15/25)
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  • Director , Regulatory Affairs…

    Gilead Sciences, Inc. (Foster City, CA)
    … Information Management system. **Qualifications** + Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs ( CMC RA) or other relevant ... guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal meetings and… more
    Gilead Sciences, Inc. (06/27/25)
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  • Sr Director , Regulatory…

    Gilead Sciences, Inc. (Foster City, CA)
    …a scientific or technical discipline required (advanced degree preferred) - with biopharma and/or regulatory affairs experience of 14+ years with a BA/BS or 12+ ... in digital or innovation roles preferred. + Strong understanding of CMC regulatory submissions and the structure/content of Module 3. + [Preferred]:… more
    Gilead Sciences, Inc. (09/04/25)
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  • Exec Director , Regulatory…

    Gilead Sciences, Inc. (Foster City, CA)
    …degree with directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas ... with an MA/MS, PhD, PharmD, or MD. + Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies,… more
    Gilead Sciences, Inc. (08/08/25)
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  • Director , Biologics Analytical Development…

    Gilead Sciences, Inc. (Foster City, CA)
    …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... Description:** **We are seeking a talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal...deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support… more
    Gilead Sciences, Inc. (07/18/25)
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  • Associate Director , Small Molecule…

    Otsuka America Pharmaceutical Inc. (Sacramento, CA)
    …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... **Associate Director , Small Molecule Analytical Development** + Lead and...and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols… more
    Otsuka America Pharmaceutical Inc. (08/27/25)
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  • Director , Submission Operations Management

    BeOne Medicines (Emeryville, CA)
    …**job:** Accountable and responsible for building and maintaining relationships within Regulatory Affairs and functional organizations including partnering with ... as CMC , Reg Strategy, Clinical/Non-Clinical, Quality/Manufacturing, GTS, Pharmacovigilance and Regulatory Compliance. This position will also play a key role in… more
    BeOne Medicines (08/01/25)
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  • Senior Scientific Director , Clinical…

    AbbVie (Irvine, CA)
    …required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May ... opinion leader interactions related to the disease area(s); partners with Medical Affairs , Commercial and other functions in these activities as required, consistent… more
    AbbVie (08/08/25)
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