• Associate Director, Regulatory CMC

    BeOne Medicines (San Mateo, CA)
    …taken when recalls or product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and ... regulatory strategies as well as authoring CTD CMC sections for the assigned project to...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
    BeOne Medicines (06/25/25)
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  • Regulatory Affairs Assoc II CMC

    Gilead Sciences, Inc. (Foster City, CA)
    …and qualifications are as follows: **Responsibilities:** + Provides support for designated regional regulatory activities for PDM CMC Project and Commercial ... Teams, Regulatory Project and Regulatory Submissions Teams, with focus on Small/Synthetic Molecules. +...manager support. + Invests in acquiring knowledge about CMC regulatory intelligence including guidelines and … more
    Gilead Sciences, Inc. (07/29/25)
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  • Senior Manager , Global Regulatory

    Otsuka America Pharmaceutical Inc. (Sacramento, CA)
    …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
    Otsuka America Pharmaceutical Inc. (06/19/25)
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  • Associate Director, Supply Chain - CMO Management…

    BeOne Medicines (Emeryville, CA)
    …cost-effective production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory , Quality to ensure on time commercial launch & new ... **_General Description:_** Sr. Manager /Associate Director, Supply Chain CMO Management & PM...a scientific field. Minimum 10 years' experience within biopharmaceutical/pharmaceutical CMC development, GMP and regulatory requirements **Computer… more
    BeOne Medicines (06/05/25)
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  • Sr Manager , Supply Chain

    Gilead Sciences, Inc. (Foster City, CA)
    …Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to ... the care of patients with life-threatening diseases. The **Sr. Clinical Supply Manager ** is a leader that inspires teams while providing expertise for Gilead's… more
    Gilead Sciences, Inc. (07/22/25)
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  • Senior Director, Product Management Team Lead…

    Gilead Sciences, Inc. (Foster City, CA)
    …Senior Director, Product Management Team Lead (Early Phase) will have experience serving as project manager for early phase biopharma molecules and will serve as ... **KEY RESPONSIBILITIES** Reporting to the Executive Director of Product & Project Management and operating within the broader Pharmaceutical Development and… more
    Gilead Sciences, Inc. (08/08/25)
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  • Sr Associate Scientist, FPD

    Gilead Sciences, Inc. (Foster City, CA)
    …Support or represent function and work collaboratively on cross-functional teams to support project team strategy and regulatory filings. . Fully embrace a ... documentation practices. . Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and… more
    Gilead Sciences, Inc. (08/02/25)
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  • QC Scientist

    Astrix Technology (San Diego, CA)
    …and day-to-day operations within the QC department + Report directly to the CMC Expert Manager **Qualifications:** + Master's degree in Chemistry (Bac+5); ... technical documentation + Perform analytical data review to ensure compliance with regulatory and quality standards + Manage and execute stability studies + Support… more
    Astrix Technology (06/10/25)
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