- CSL Behring (King Of Prussia, PA)
- … regulatory activities as assigned, inclusive of potential to lead core document preparation (** **e.g.** **core briefing book, pediatric plans, etc.), ... product filing preparation activities (investigational, new and marketed) and health authority...GRL.** **Actively contribute to the GRAST activities, strategy development, document reviews and competitive regulatory intelligence.** **Ensures… more
- 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
- Sumitomo Pharma (Harrisburg, PA)
- …of effectively negotiating with others while maintaining composure + Development and preparation of successful regulatory strategies and the ability to ... contribute to the development and writing of a regulatory strategy document + Ability to learn new therapeutic areas when necessary + Prior history with… 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
- 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
- ICON Clinical Research (Blue Bell, PA)
- …+ Strong understanding of regulatory requirements and industry standards for regulatory and clinical document development + Solid understanding of common ... Writer will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical… more
- University of Pennsylvania (Philadelphia, PA)
- …entities. Correspond regularly with the Institutional Review Board and other regulatory agencies, including preparation and submission of protocols, protocol ... submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. This position is responsible for… more
- Williams Companies (Tunkhannock, PA)
- …with preparation of environmental reports, plans and inventories for regulatory authorities + Responds to requests from internal and/or external customers + ... remain within legal limits. Your day includes gathering operational data, submitting regulatory reports, and handling permit renewals under tight deadlines. You will… 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