• 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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  • Senior CMC Project Manager

    Abeona (Cleveland, OH)
    Position Overview We are seeking a highly skilled and driven Senior Manager of Project Management to lead and drive strategic execution of multiple ... commercialization and capacity expansion objectives. + Collaborate with Clinical Operations, Regulatory , Medical Affairs, CMC , Biometrics, and other functional… more
    Abeona (08/07/25)
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  • Scientific Director/Senior Scientific Director,…

    Bristol Myers Squibb (New Brunswick, NJ)
    …and pivotal clinical studies, through to market application approvals (BLA, NDA) in partnership with CMC Team Project Manager . + Accountable for CMC ... Product Development and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC , Commercial Manufacturing, etc.) to define and… more
    Bristol Myers Squibb (08/26/25)
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  • Senior Manager , Global Regulatory

    Otsuka America Pharmaceutical Inc. (Columbus, OH)
    …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. (08/22/25)
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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 Director, Project Management - Oversight…

    ThermoFisher Scientific (Wilmington, NC)
    …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... depend on - now and in the future. Our Project Delivery colleagues within our PPD(R) clinical research services...global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC more
    ThermoFisher Scientific (08/17/25)
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  • Sr Director, Project Management,…

    ThermoFisher Scientific (Wilmington, NC)
    …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more
    ThermoFisher Scientific (06/05/25)
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  • Principal Research Scientist I, Analytical…

    AbbVie (North Chicago, IL)
    …Chemistry, Process Engineering, Drug Product Development (DPD), and Quality Assurance (QA) and CMC - Regulatory . Responsibilities: + Manager a small team (3 ... R&D) is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products.… more
    AbbVie (08/15/25)
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  • Manager , Global Labeling Operations

    J&J Family of Companies (Raritan, NJ)
    …initiatives in partnership with Global Labelling Product Leaders, Supply Chain, Marketing, Regulatory Affairs, CMC Regulatory Affairs, Product Artwork, and ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions… more
    J&J Family of Companies (08/21/25)
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  • Sr Manager , Supply Chain

    Gilead Sciences, Inc. (Parsippany, NJ)
    …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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