- University of Pennsylvania (Philadelphia, PA)
- …and serve as a key departmental stakeholder representing the department/division related to regulatory audits by the FDA , EMA, other Competent Health Authorities ... programs and resources, and much more. Posted Job Title Associate Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job… more
- Teva Pharmaceuticals (West Chester, PA)
- …role that will be responsible for developing, coordinating, and implementing regulatory strategies for drug development programs for innovative biologic ... Director, Regulatory Affairs Date: Dec 2, 2025 Location: West... knowledge of and submission experience with investigational new drug applications (INDs) and new drug applications… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory … more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA or other health authority ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...JPMA, etc.). + Demonstrate solid working knowledge of the drug , biologic, and device development process, laws, regulations, and… more
- GRAIL (Harrisburg, PA)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… more
- Parexel (Harrisburg, PA)
- …and/or drug -device combination products are a plus) * Support regulatory leads in developing contingency plans for CMC-related scenarios * Represent CMC ... for a Senior Consultant * Proven success in preparing regulatory documentation for FDA , EMA, and Health...Health Canada (IND, NDA, DMF) * In-depth understanding of drug development, manufacturing processes, GMP, and regulatory … more
- Parexel (Harrisburg, PA)
- …looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team! A ... At **Parexel** , we don't just support drug development-we help shape it. As a **Senior/Vice... regulatory applications. + Previous experience with a regulatory agency (such as the FDA or… more
- Teleflex (Wyomissing, PA)
- … compliance activities, including Health Canada license renewals, Food and Drug Administration ( FDA ) product device listings, establishment registrations, ... Sr. Regulatory Affairs Associate **Date:** Nov 24, 2025 **Location:**...a difference in patients' lives. **Position Summary** The Sr Regulatory Affairs (RA) Associate will be responsible for a… more
- ThermoFisher Scientific (Allentown, PA)
- …intelligence within the biopharmaceutical industry. + Strong understanding of global regulatory frameworks and drug development lifecycle. + Excellent ... depend on - now and in the future. ROLE: Regulatory Intelligence Manager LOCATION: Fully Remote, East Coast is...changes, guidance documents, and policy trends across key markets ( FDA , EMA, PMDA, etc.) or stakeholders (EU Commission, ICH,… more
- West Pharmaceutical Services (Exton, PA)
- …+ Minimum 5 years of relevant experience + 2+ years of medical device regulatory experience preferred + Experience with US FDA regulations (Title 21CFR820), EU ... Senior Regulatory Affairs Specialist Requisition ID: 71673 Date: Nov...affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening. **Nearest Major Market:**… more