• Manager , Regulatory CMC

    Kelly Services (Winston Salem, NC)
    **Job Title: Manager , Regulatory CMC (Contractor)** **Hourly Pay Rate: $62.50** **Schedule: Monday-Friday, 9:00 AM-5:00 PM (Must work Eastern Time hours)** ... Remote** **Position Summary:** An advanced therapy biotech organization is seeking a ** Manager , Regulatory CMC (Contractor)** to provide specialized support… more
    Kelly Services (07/30/25)
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  • Senior Regulatory Affairs Specialist

    Grifols Shared Services North America, Inc (Clayton, NC)
    …The purpose of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
    Grifols Shared Services North America, Inc (05/14/25)
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  • Senior Manager , Global Regulatory

    Otsuka America Pharmaceutical Inc. (Raleigh, NC)
    …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
    Otsuka America Pharmaceutical Inc. (06/19/25)
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  • Sr Director, Project Management,…

    ThermoFisher Scientific (Wilmington, NC)
    …deliverables + Advanced, broad understanding of global/regional/national country requirements/ regulatory affairs procedures for clinical trial authorization, ... in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee​ providing...global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC more
    ThermoFisher Scientific (06/05/25)
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