• Senior Manager, Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
    …working in the pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
    Otsuka America Pharmaceutical Inc. (06/19/25)
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  • Sr. CIP Regulatory Compliance Spec I

    Duquesne Light Company (Pittsburgh, PA)
    …(NERC) Critical Infrastructure Protection (CIP) Reliability Standards, the **CIP Regulatory Compliance Specialist** will review and assist in the coordination ... of operational and technical regulatory compliance processes for the Company including evaluation of...and monitoring of compliance with existing regulations, and the preparation of compliance related documentation. Monitor changes in requirements… more
    Duquesne Light Company (06/24/25)
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  • Regulatory Compliance Manager - Food…

    Rise Baking Company (York, PA)
    … policies, processes, and SOPs + Provide training and guidance to the regulatory compliance team + Oversee the preparation , collection, and coordination of ... Job Purpose Lead the daily activities of the regulatory compliance team, ensuring they have the necessary...data is current and accurate + Manage data and document compilation for the development of individual product specification… more
    Rise Baking Company (06/17/25)
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  • Senior Regulatory Specialist

    Globus Medical, Inc. (Audubon, PA)
    …Clinical Affairs personnel, as needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling ... their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions,… more
    Globus Medical, Inc. (08/02/25)
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  • Regulatory Specialist

    Globus Medical, Inc. (Audubon, PA)
    …Clinical Affairs personnel, as needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling ... can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance for… more
    Globus Medical, Inc. (06/25/25)
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  • Ambulatory Care Clinical Pharmacy Specialist,…

    Penn Medicine (Philadelphia, PA)
    …seeking a full-time, day shift, hybrid Ambulatory Care Clinical Pharmacy Specialist, Regulatory for the Hospital of the University of Pennsylvania (HUP). Summary: ... The Clinical Pharmacy Specialist, Regulatory (CPS-R) ensures pharmacy compliance related to ...IFTA. The CPS-R will conduct process owner interviews and document end-to-end process flow charts for in-scope processes while… more
    Penn Medicine (08/07/25)
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  • Regulatory Associate

    Globus Medical, Inc. (Audubon, PA)
    …Clinical Affairs personnel, as needed for IDE and PMA reporting + Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling ... resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance for… more
    Globus Medical, Inc. (06/25/25)
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  • GRA CMC Lead, Vaccines

    Sanofi Group (Swiftwater, PA)
    …Affairs, Global Regulatory Affairs. + Coordinate the submission of CMC regulatory files and contribute to the preparation and review; in collaboration ... of success. + Draft or contribute to the drafting, preparation , review and approval of supporting documents for consultation...within the time allotted. + Author the CMC strategy document "Global Regulatory CMC Strategy Document… more
    Sanofi Group (07/02/25)
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  • Medical Writing Clinical Publisher

    Teva Pharmaceuticals (West Chester, PA)
    …in meetings for submissions and others as requested + Participates in the preparation /revision of document templates, development of process, and preparation ... product and program level Preferred: + 2 Years of experience related to clinical document publishing or regulatory submission publishing + 2 Years of experience… more
    Teva Pharmaceuticals (07/22/25)
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  • Clinical Research Coordinator B/C (Abramson Cancer…

    University of Pennsylvania (Philadelphia, PA)
    …subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The successful candidate will comply with all policies relating ... to the University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards. The Clinical Research Coordinator (CRC) is an integral and essential… more
    University of Pennsylvania (08/03/25)
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