• Head of COA Regulatory Strategy, Patient…

    IQVIA (Durham, NC)
    …true expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... Lead development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED + Contribute to the enhanced… more
    IQVIA (07/01/25)
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  • Director, Regulatory Advertising…

    Sumitomo Pharma (Raleigh, NC)
    …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
    Sumitomo Pharma (07/08/25)
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  • Manager, Regulatory CMC - Remote

    Kelly Services (Winston Salem, NC)
    …to support regulatory filings. + Ensure that all documentation aligns with regulatory standards ( FDA , EMA, ICH) and internal SOPs. + Assist in preparing ... development, manufacturing, or process development. + Experience with global regulatory filings and knowledge of FDA , EMA,...with global regulatory filings and knowledge of FDA , EMA, and ICH guidance. + Exceptional written and… more
    Kelly Services (07/30/25)
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  • Manufacturing Process Specialist

    J&J Family of Companies (Wilson, NC)
    …efforts. + Serves as Subject Matter Expert (SME) during internal and external regulatory audits (including FDA , EMEA). + Maintains various databases of ... to thrive in a multi-cultural and matrixed environment. + Knowledge of FDA /EMEA regulatory requirements related to biologics and/or pharmaceuticals, preferred. +… more
    J&J Family of Companies (08/01/25)
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  • Therapeutic Strategy VP, Rare Disease…

    IQVIA (Durham, NC)
    …to make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. ... from discovery to market. You will oversee preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy, and assess the risk and probability… more
    IQVIA (07/23/25)
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  • Change Control Systems Specialist

    Biomat USA, Inc. (Research Triangle Park, NC)
    …Skills and Abilities:** + Strong knowledge of Food and Drug Administration ( FDA ) regulatory requirements for good manufacturing practices. + Demonstrated ... reviewed, justified, documented, approved, and implemented in conformance with regulatory requirements and company policies / procedures. **Primary Responsibilities:**… more
    Biomat USA, Inc. (08/08/25)
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  • Production Manager - Protein

    US Foods (Lexington, NC)
    …the lowest unit cost and manages staff to ensure the integrity, USDA / FDA regulatory compliance, sanitation, shipping receiving and inventory control. **We help ... deadlines and quality specifications are met in accordance with internal and regulatory guidelines * Establishes and maintains cross functional relationships in a… more
    US Foods (07/25/25)
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  • Facilities Services Coordinator

    Herbalife (Winston Salem, NC)
    …experience or similar job experience* 5+ years' experience in cGMP, FDA regulatory requirements* Experience supporting the development/tracking of project ... Anniversary celebrations, etc.). Will coordinate documentation processes to support internal regulatory requirements and assisting in the management and care of… more
    Herbalife (07/12/25)
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  • Sr Manager, IT Business Analysis - SAP BRH…

    Gilead Sciences, Inc. (Raleigh, NC)
    …The ideal candidate will possess deep expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and ... comply with relevant Life Sciences industry regulations, including GxP, FDA , EMA, and other regulatory bodies. +...regulations, including GxP, FDA , EMA, and other regulatory bodies. + Lead the development of validation strategies… more
    Gilead Sciences, Inc. (07/10/25)
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  • MS&T Director - Sterile Technical SME (Visual…

    ThermoFisher Scientific (Wilmington, NC)
    …technologies and ensure timely product launches + Monitor GMP, EU, and FDA regulatory changes and requirements, review industry-specific journals and periodicals ... to the specialist area of expertise + Validated process understanding (Pharma, GMP, Regulatory aspects) + Up to 30-40% travel, as needed + Confident communicator… more
    ThermoFisher Scientific (05/23/25)
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