• Senior Manager, CMC Global…

    Otsuka America Pharmaceutical Inc. (Raleigh, NC)
    …discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC , with significant experience in small molecules is ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing… more
    Otsuka America Pharmaceutical Inc. (12/02/25)
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  • Senior Regulatory Affairs…

    Parexel (Raleigh, NC)
    … regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate, you will serve as the primary ... to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and...in line with local legislation (renewals, PSURs, label updates, CMC changes). * Execute timely data entry and validation… more
    Parexel (12/20/25)
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  • Associate Director, Regulatory…

    Sumitomo Pharma (Raleigh, NC)
    …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the US....the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of … more
    Sumitomo Pharma (10/11/25)
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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. (11/20/25)
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  • Director, Clinical Regulatory…

    ThermoFisher Scientific (Wilmington, NC)
    …Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** Join Us as a Director Regulatory Affairs - Make an Impact at the Forefront of ... Innovation The Director Regulatory Affairs provides operational leadership for the...guidelines; advanced knowledge of at least one of the regulatory specialty areas: preclinical, clinical, CMC , publishing,… more
    ThermoFisher Scientific (01/03/26)
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  • Sr Director, Project Management,…

    ThermoFisher Scientific (Greenville, NC)
    …deliverables + Advanced, broad understanding of global/regional/national country requirements/ regulatory affairs procedures for clinical trial authorization, ... 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 (12/03/25)
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