- Cardinal Health (Harrisburg, PA)
- …research, industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions ... knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct...Support research to maintain a pulse on product, supplier, regulatory , and market dynamics; understand how industry trends may… more
- Organon & Co. (Plymouth Meeting, PA)
- …products, in order to optimize label and obtain shortest time to approval by regulatory agencies, including but not limited to US- FDA or EU procedures ... company with external organizations through direct communication with the FDA , EMA, or other EU regulatory agencies,...or EMA; prepare our company's teams for meetings with FDA or EMA at any phase of drug… more
- IQVIA (Wayne, PA)
- …true expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... and consortia + Lead development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED + Contribute to the… 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 ... position entails development of FDA submissions, requires working knowledge of products under review...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… 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 ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining...position entails development of FDA submissions, requires working knowledge of products under review… more
- Sumitomo Pharma (Harrisburg, PA)
- …a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, guidance ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … 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
- Merck (North Wales, PA)
- …quality and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, ... in biological sciences, chemistry, or related discipline with 10+ years of relevant drug development, clinical, or regulatory experience. + MD or Ph.D./Pharm D… more
- Charles River Laboratories (Wayne, PA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will...River operations and serves as a member of the Regulatory Affairs and Compliance management team. Provides direction in… more
- Pfizer (Collegeville, PA)
- …Regulatory and Cross-functional teams, managing submissions, and interacting with Regulatory agencies worldwide (Influenza/COVID-19) or the US FDA (COVID-19). ... local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your… more