- 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
- Duquesne Light Company (Pittsburgh, PA)
- …processes, business units and oversight responsibilities. Responsible for assisting the Regulatory Compliance Senior Managers with NERC CIP and O&P compliance ... focus upon always being "audit ready." + Responsible for assisting the Regulatory Compliance Senior Managers in coordinating compliance audits by the Federal Energy… more
- 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
- 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
- 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. (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
- 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
- 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
- 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
- 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