- PNC (Pittsburgh, PA)
- …remotely, at manager 's discretion. The opportunity lies within PNC's Regulatory Reporting department, specifically the Finance Data Submissions team which ... success. As a Sr. Business Analytics Consultant within PNC's Regulatory Reporting organization, housed within the Office of the...for filing the Federal Reserve FR Y14Q/M CCAR data submissions . This role is an opportunity to navigate the… more
- Sumitomo Pharma (Harrisburg, PA)
- …agencies. + Understands evolving Health Authority (HA) standards and procedures for regulatory submissions . Guides and trains project teams on new requirements, ... a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the Senior Manager … more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …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
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …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
- Teva Pharmaceuticals (West Chester, PA)
- Director, Regulatory Affairs - Dossier Project Manager Date: Jul 19, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... a difference, and new people to make a difference with. **The opportunity** The Regulatory Innovative Medicine Dossier Project Manager , a key member of Global … more
- Deloitte (Pittsburgh, PA)
- …available Preferred: + Understanding of pharmaceutical regulatory data and regulatory filing requirements and generating submissions packages + Experience ... role ends on 8/31/2025 Work You'll Do As a Manager you will lead and deliver engagements, or components...4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like… more
- Globus Medical, Inc. (Audubon, PA)
- …medical device development and registration of products + Demonstrated knowledge of US regulatory submissions ; Pre-Sub, and 510(k); working knowledge of IDE and ... Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for...PMA submissions a plus + Experience assessing regulatory … more
- Globus Medical, Inc. (Audubon, PA)
- …their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions ... II and class III products. This position entails development of FDA submissions , requires working knowledge of products under review and of relevant regulations… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance for ... 510(k) submissions , and approval for IDE/PMA submissions to...Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for… more
- University of Pennsylvania (Philadelphia, PA)
- …participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory Affairs ... documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions , continuing reviews, amendments,… more
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