• Associate Director, Regulatory CMC…

    BeOne Medicines (San Mateo, CA)
    …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...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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  • AI & Data Manager - Life Sciences R&D…

    Deloitte (San Jose, CA)
    …(ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years ... equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components...+ 4+ years Life Sciences Chemistry, Manufacturing, and Controls ( CMC ) experience to include: + Introducing new technologies like… more
    Deloitte (07/17/25)
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  • Senior Manager , Global Regulatory…

    Otsuka America Pharmaceutical Inc. (Sacramento, CA)
    …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
    Otsuka America Pharmaceutical Inc. (08/22/25)
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  • AI & Data Manager - Life Sciences R&D…

    Deloitte (San Jose, CA)
    …Recruiting for this role ends on 9/14/2025 Work You'll Do As a Manager you will lead and deliver engagements, or components of large, complex engagements. ... experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and… more
    Deloitte (07/09/25)
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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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  • Vice President, Strategic Sourcing

    Vera Therapeutics (Brisbane, CA)
    …with a strong focus on vendor selection and performance management, regulatory compliance, risk mitigation, contract oversight & management and operational ... excellence. Critical partners for these activities include CMC & Clinical Operations. This person will oversee clinical and commercial supply chains, ensuring… more
    Vera Therapeutics (08/09/25)
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  • Director, Strategist QC & Analytics Cell Therapy

    Bayer (Berkeley, CA)
    …a focus on cell therapy; + Comprehensive knowledge and understanding of CMC -related regulatory frameworks pertaining to clinical development and license ... at Bayer is instrumental in providing strategic, scientific, and regulatory guidance for our late-stage cell therapy pipeline with...+ Proven experience as a QC project lead or manager for clinical stage program (ideally late phase) or… more
    Bayer (08/27/25)
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  • Sr Associate Scientist, FPD

    Gilead Sciences, Inc. (Foster City, CA)
    …documentation practices. . Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and ... in project meetings. . Analyze data and draft conclusions before discussing with manager or supervisor. . Support or represent function and work collaboratively on… 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 (08/11/25)
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  • Senior Director, Product Management Team Lead…

    Gilead Sciences, Inc. (Foster City, CA)
    …Product Management Team Lead (Early Phase) will have experience serving as project manager for early phase biopharma molecules and will serve as a subject matter ... translational science, biomarker strategy, and early clinical trial design. + Regulatory knowledge: Familiarity with FDA/EMA guidance for preclinical and early… more
    Gilead Sciences, Inc. (08/08/25)
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