- RWJBarnabas Health (West Orange, NJ)
- …NJ + Minimum of 8 years of legal experience, including substantial experience with clinical research, FDA regulatory compliance, and research contracting + ... Senior Counsel, Assistant Vice President of Legal Affairs , Clinical Research & Regulatory...and multi-site trial oversight + Counsel stakeholders on Good Clinical Practice, FDA inspection readiness, and compliance… more
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Regulatory Affairs Specialist Job Profile Title Clinical ... Research Regulatory Specialist B Job Description Summary Regulatory Affairs as a field is concerned...in obtaining and maintaining institutional and governmental approval for clinical trials. These trials often include FDA -regulated… more
- J&J Family of Companies (Danvers, MA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... are searching for the best talent for a **Manager, Regulatory Affairs ** to support our Heart Recovery...lead compilation of all materials required for submissions to FDA . + Independently support clinical programs including… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …a typical day might include:** The Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in ... typically carrying out the responsibilities with guidance from the Regulatory Affairs , Advertising and Promotion Director. The...Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned… more
- 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
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced ... carrying out the responsibilities with minimal guidance from the Regulatory Affairs , Advertising and Promotion Director. The...Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned… more
- Sumitomo Pharma (Washington, DC)
- …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
- 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
- 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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …you to broaden your expertise and grow in your career. Our Staff Regulatory Affairs Specialist position is primarily focused on maintaining continued market ... independently and as part of a team. The Staff Regulatory Affairs Specialist will work in BD...+ Demonstrated success in the preparation and completion of regulatory submissions (Qsub, PMA, 510(k), IDE) to FDA… more
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