- 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
- Boehringer Ingelheim (Athens, GA)
- …Director, US Regulatory Affairs Pharmaceuticals is a key interface with US Regulatory Authorities such as the FDA & EPA and drives regulatory ... Ingelheim's high regard for our employees. The Director, US Regulatory Affairs Pharmaceuticals leads the US ...for all new product types and entities licensed via FDA -CVM & EPA and as well as Life Cycle… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …improving the lives of patients for generations to come. As an Associate Director, Global Regulatory Affairs , you will act as the Regional Regulatory Lead on ... or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. Position will be filled...+ In-depth understanding of US Food & Drug Administration ( FDA ) and European Medicines Agency (EMA) regulatory … more
- Abbott (Plymouth, MN)
- …with their lives. **The Opportunity** Abbott is seeking a passionate, experienced **Senior Regulatory Affairs Specialist** to join our team on-site in Plymouth, ... affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory… more
- J&J Family of Companies (Irvine, CA)
- …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 ** . _The preferred location for... _highly desired_ . + Working knowledge of US FDA & EU MDR regulatory requirements &… more
- Danaher Corporation (Miami, FL)
- …possess previous experience in: . Prior internship or coursework in regulatory affairs or quality assurance . Understanding of FDA , EMA, or ICH guidelines ... the Danaher Business System which makes everything possible. The Regulatory Affairs Intern will gain hands-on experienc.... Collaborate with cross-functional teams including R&D, Quality, and Clinical Affairs . Help ensure compliance with… more
- Sanofi Group (Framingham, MA)
- **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
- Stryker (Redmond, WA)
- We are currently seeking a **Senior Regulatory Affairs Specialist** to join our **Medical** **Division** to be based **Hybrid** in **Redmond, Washington.** As ... part of the Medical Regulatory Affairs team, you will work with...appropriate communication tools. + Evaluate proposed pre- clinical , clinical , and manufacturing changes for regulatory filing… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …strategic legal advisor to multiple internal stakeholders, including the commercial, medical affairs , regulatory , HEOR, corporate affairs , and compliance ... This position with the Regeneron Regulatory and Commercial Law team will provide proactive...business areas supported + Advising on data disclosures following clinical development milestones via press releases and US or… more
- Sumitomo Pharma (Lincoln, NE)
- …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