- 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
- Sumitomo Pharma (Trenton, NJ)
- …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
- 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
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... Development, LLC is looking is recruiting for a **Lead Regulatory Scientist, Global Regulatory Affairs ...in the development and improvement of processes related to regulatory submissions + Review clinical trial plans… more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs ** . The Director is part of the Global ... Regulatory Affairs (GRA) team based in the...Regulatory Affairs (GRA) team based in the US. He/she will... templates + Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical … more
- Sanofi Group (Morristown, NJ)
- …+ Provide regulatory labeling leadership to cross-functional teams ( Regulatory Strategy, Clinical Development, Medical Affairs , Pharmacovigilance, ... **Job Title:** Director, Global Regulatory Affairs - Global Labeling Strategy...shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including… more
- System One (Florham Park, NJ)
- Job Title: AD or Director, Regulatory Affairs Strategy Location: Florham Park, NJ (10 days onsite per month) Type: 12-month contract Must haves: + Must be local ... in IND/NDA development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director) in developing and executing regulatory… more
- Sumitomo Pharma (Trenton, NJ)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the...to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? ... approvals through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role… more
- Bayer (Whippany, NJ)
- …minds to make a real difference, there's only one choice.** **Manager Regulatory Affairs ** **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of ... this role, Manager Regulatory Affairs , are to: + Provides ...Brand group with respect to potential business opportunity; 2) Clinical /Medical with respect to data necessary to support safety… more
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