- University of Pennsylvania (Philadelphia, PA)
- …comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator ... research investigators, Research Team Leaders, our clinical research nurse(s), and regulatory coordinator. The ACC received an exceptional rating from the National… more
- Pfizer (Harrisburg, PA)
- …Injectables experience, including buy-and-bill strategies and demonstrated knowledge of: Regulatory pathways ( FDA , EMA, Health Canada) and interchangeability ... public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses… more
- Genentech (Philadelphia, PA)
- …mixed models) and tools such as R and JMP. + Familiarity with regulatory guidelines ( FDA , EMA), strong collaborative skills for working in multidisciplinary ... multiple disparate sources. + Keep current with emerging methodologies, regulatory requirements, and industry trends through continuous learning and professional… more
- Cytel (Harrisburg, PA)
- …comfortable interfacing with **senior executives** . + Experience interacting with ** regulatory agencies ( FDA /EMA)** and **key opinion leaders (KOLs)** . ... collaborating with a team of consultants and analysts to define optimal ** regulatory , clinical, and/or market access pathways** . + Develop **innovative solutions**… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …and provide recommendations. + Coordinates and leads audit activities with all global regulatory agencies (eg FDA , Notified Bodies, PMDA, NMPA etc.) + Creates ... Global Vice President QARA Compliance provides assurance and manages all aspects of Regulatory Compliance. The focus will be over the implementation of the Global… more
- Deloitte (Pittsburgh, PA)
- …support. + Regulatory Compliance: Ensure all solutions and processes meet global regulatory requirements (eg, FDA , EMA, PMDA) and industry best practices. + ... You will lead and deliver complex projects that drive innovation, regulatory compliance, and operational excellence for pharmaceutical, biotech, and medical device… 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 ... for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This...and PMA reporting + Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performing… more
- CSL Behring (King Of Prussia, PA)
- …including integrated analyses for submissions. + Represent Biostatistics in interactions with regulatory authorities (eg, FDA , EMA, PMDA) + Be responsible for ... program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the… more
- J&J Family of Companies (Spring House, PA)
- …minimum of 10 years of global health regulated industry is required. + Global regulatory experience with deep expertise in US FDA , EMA, and international ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director, Regulatory Affairs Date: Dec 2, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: 65114 **Who ... people to make a difference with. **The opportunity** The Associate Director, Global Regulatory Affairs, will be responsible for providing regulatory guidance to… more