• Senior Manager , Global Regulatory

    Otsuka America Pharmaceutical Inc. (Raleigh, NC)
    …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. (11/20/25)
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  • Sr Oversight Director, Project Management…

    ThermoFisher Scientific (Greenville, 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 (10/15/25)
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  • Sr Director, Project Management,…

    ThermoFisher Scientific (Greenville, 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 (09/03/25)
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  • Senior Clinical Trial Manager , FSP

    ThermoFisher Scientific (Wilmington, NC)
    …consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, ... members involved in the study set up (DM, Reg, CMC etc ): ensure feasibility report are exhaustive, Review...activity timelines and metrics, providing status updates to the project manager , regularly reviewing projects using tracking… more
    ThermoFisher Scientific (10/25/25)
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  • Principal Scientist 1 - Chemical Research…

    Cambrex High Point (High Point, NC)
    …of the industrial regulatory landscape; Good understanding of site SOPs and regulatory CMC concerns and can answer client questions that can help to ... use. ► Work closely with other chemistry and analytical laboratory staff to coordinate project activities and resource usage. ► Work to ensure that a spirit of… more
    Cambrex High Point (08/30/25)
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