• International Regulatory Affairs…

    Cardinal Health (Richmond, VA)
    …and risks for products and develops plans for product development programs and regulatory submissions . **_Job Summary_** The Manager , Regulatory ... matter expertise to provide services in technical writing and regulatory submissions as well as clinical research... authorities and provides insights to senior leadership regarding regulatory developments. The Manager leads a team… more
    Cardinal Health (05/05/25)
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  • Senior Manager , Global Regulatory…

    Otsuka America Pharmaceutical Inc. (Richmond, VA)
    …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with… more
    Otsuka America Pharmaceutical Inc. (04/23/25)
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  • R&D Regulatory Manager

    Grifols Shared Services North America, Inc (Roanoke, VA)
    …the scope of experimentation and the selection of data needed to support regulatory submissions . + Interacts with regulatory authorities regarding programs ... and development of contingency plans. + Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements… more
    Grifols Shared Services North America, Inc (05/02/25)
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  • Senior Manager , CMC Global…

    Otsuka America Pharmaceutical Inc. (Richmond, VA)
    Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project ... ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of responsibility include… more
    Otsuka America Pharmaceutical Inc. (04/26/25)
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  • Environmental Regulatory Permitting Project…

    Stantec (Fredericksburg, VA)
    …+ Create technical documents and provide review of technical documents that support regulatory submissions . + Support and ensure implementation of Health, Safety ... Environmental Regulatory Permitting Project Manager - FERC/Energy - ( 250001F3 ) **Description** Grounded in safety, quality, and ethics, our experts lead their… more
    Stantec (04/03/25)
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  • Chief Licensing Manager

    Bechtel Corporation (Reston, VA)
    …Job Summary: We are looking for a knowledgeable and experienced Chief Licensing Manager to ensure compliance with all regulatory requirements related to nuclear ... agencies. Responsible for leading critical engagements, spanning from topical report submissions to licensing applications. Leading key regulatory projects,… more
    Bechtel Corporation (05/14/25)
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  • Process Manager (TS/SCI) (Ft. Belvoir, VA)

    SMX (Fort Belvoir, VA)
    …and overseeing cybersecurity-related policies and procedures to maintain data integrity and regulatory compliance. As the APL Manager , this individual develops ... Process Manager (4224) (TS/SCI) (Ft. Belvoir, VA)at SMX(View all...product evaluation, conducts detailed reviews of hardware and software submissions , and collaborates with cross-function teams to promote the… more
    SMX (04/03/25)
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  • Environmental Data Manager

    Leidos (Reston, VA)
    …(QA)/Quality Control (QC), report preparation and submittal, and final data submissions ). The Environmental Data Manager will support many environmental ... Leidos currently has an opening for an **Environmental Data Manager ** , this position is fully remote or hybrid...include field measurements and screening data, state and federal regulatory values, sample chains of custody, laboratory methods and… more
    Leidos (04/23/25)
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  • Senior Manager of Biostatistics

    Sumitomo Pharma (Richmond, VA)
    …medical writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and ... Safety (ISS) and Integrated Summary of Efficacy (ISE) strategy for NDA/BLA submissions , ensuring compliance with regulatory expectations. + Collaborate closely… more
    Sumitomo Pharma (04/24/25)
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  • Senior Manager , Ad Policy, International…

    Amazon (Arlington, VA)
    Description *The primary stakeholder for this policy manager position will be the Sales organization and Sales leaders. This position will require a minimum of 40% ... Amazon and that growth generates challenges in managing huge volumes of advertising submissions while maintaining a high customer experience and working at the speed… more
    Amazon (04/18/25)
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