- Legend Biotech USA, Inc. (Philadelphia, PA)
- …interpret data.Serve as the primary toxicology subject matter expert for interactions with regulatory agencies ( FDA , EMA, etc.); support or lead preparation of ... from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline of… more
- Merck & Co. (North Wales, PA)
- …and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development ... PreNDA-and PreBLA-meeting preparation, study data standards plan, preparing questions for FDA edata-mailboxes (CBER/CDER), attendance at meetings with regulatory … more
- Pfizer (Collegeville, PA)
- …study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. Foster a transparent environment that builds strong partnerships ... external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision… more
- University of Pennsylvania (Philadelphia, PA)
- …Regulatory Affairs Specialist C will, independently prepare and process all regulatory documentation/applications for the FDA and requisite review committees. ... and contribute to the development/maintenance of study-specific case report forms for FDA reporting, as well as provide direct regulatory /compliance guidance.… more
- Sumitomo Pharma (Harrisburg, PA)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... proposed claims and assess consistency of proposed claims with FDA -approved labeling + Provide regulatory leadership to...experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs) + NDA… more
- Globus Medical, Inc. (Audubon, PA)
- …and gaining approval of 510(k), IDE, and PMA submissions to the US Food and Drug Administration ( FDA ) for class II and class III products. This position entails ... Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …products and drug -device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global … more
- Globus Medical, Inc. (Audubon, PA)
- …clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This ... lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining...position entails development of FDA submissions, requiring working knowledge of products under review… 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
- 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
