- Boehringer Ingelheim (Ridgefield, CT)
- … strategy expertise/knowledge in one or more therapeutic areas. Interact effectively within Regulatory Affairs and across functions, as a US regulatory ... common goals for assigned projects, with supervision. With supervision, the Product Group Regulatory Affairs Fellow will: + Regulatory Professionalism: + As… more
- General Dynamics Information Technology (Fort Detrick, MD)
- …**The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs , compliance, and clinical support professionals dedicated ... drug, biologic, medical device, and combination products.** **The Regulatory Affairs Scientist will ensure compliance with FDA Sponsor responsibilities,… more
- Boehringer Ingelheim (Ridgefield, CT)
- … and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs . This position will ... **Description** The Clinical Development and Medical Affairs Fellow...reflect Boehringer Ingelheim's high regard for our employees. The Regulatory Affairs (RA) Fellowship within the Chemistry,… more
- Sumitomo Pharma (Little Rock, AR)
- …dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced ... individual will be responsible for leading development of all non- clinical and clinical regulatory strategies...to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an… more
- PCI Pharma Services (Rockford, IL)
- …across our global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives ... matters of government and regulations, with respect to the FDA , DEA, MHRA, EEU, State of Illinois, and other...and applied by all appropriate personnel. + Assists the Regulatory Affairs Manager by hosting audits, developing… more
- Actalent (Grand Rapids, MI)
- …a regulated pharmaceutical or medical device industry with hands-on Regulatory Affairs experience. + Working knowledge of FDA /ICH regulations, GDUFA, and ... Job Title: Regulatory Affairs SpecialistJob Description The Senior...sponsors and application/license holders for sterile injectable products from clinical through commercial phases. This role manages a broad… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Manager, Regulatory Affairs , is responsible for preparing, filing and gaining approval ... labeling in terms of indications and reimbursement. + Works with Product Development, Clinical Affairs , Quality, Management and other areas of the organization… more
- Kelly Services (Bridgewater, NJ)
- ** Regulatory Affairs Specialist** Kelly Science and Clinical is seeking a ** Regulatory Affairs Generalist** **for** our client a leading medical ... matter experts in nonclinical, clinical , and medical affairs . + Provide operational and administrative regulatory ...medical affairs . + Provide operational and administrative regulatory writing (cover letters, FDA forms, and… more
- Boehringer Ingelheim (Ridgefield, CT)
- … and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs . This position will ... **Description** The Regulatory Affairs Fellow - Advertising and...compliance with the Food Drug and Cosmetic Act (FDCA), FDA Guidance, and the current Regulatory landscape.… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the… more