- BeOne Medicines (Emeryville, CA)
- …an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory CMC team based ... China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory submissions and health… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics....the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD … more
- AbbVie (Irvine, CA)
- …Description Further develop your expertise and join our team as Director, CMC Product Development - Late Stage, Operations. The Product Development Director (PDD) ... be responsible for pipeline programs from a Chemistry, Manufacturing, and Controls ( CMC ) perspective. They will lead the Product Presentation and Device Strategy… more
- Lilly (Indianapolis, IN)
- …people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the scientific and regulatory efforts of ... the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities for Lilly's synthetic molecule portfolio. This… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** GRA CMC Lead, Vaccines **Location** : Swiftwater, PA or Morristown, PA **About the Job** Are you ready to shape the future of medicine? The race is on ... in helping our teams accelerate progress. The Manager, Global Regulatory Affairs - CMC has the responsibility of one or several products/valences in the Reg … more
- Sanofi Group (Swiftwater, PA)
- **Job Title:** GRA CMC Lead, Vaccines **Location:** Morristown, NJ/ Swiftwater, PA **About the Job** Are you ready to shape the future of medicine? The race is on to ... in helping our teams accelerate progress. The Chemistry, Manufacturing and Controls ( CMC ) regulatory team is accountable for the global regulatory strategy for… more
- Sanofi Group (Waltham, MA)
- **Job Title:** Head of CMC Process Standards - Vaccines **Location** : Waltham, MA **About the Job** As **Head of CMC Process Standards** group within Global ... CMC Process Development and Industrialization ( CMC PD&I) function, you will manage a group of...(QbD) and Process Validation SMEs to establish phase appropriate CMC development and process validation standards and its deployment… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of regulatory ... this position you will be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality CMC … more
- Lilly (Indianapolis, IN)
- …better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients who ... Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC... CMC commercial solid oral products will use CMC technical knowledge and regulatory science expertise to drive… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are seeking a highly motivated and experienced Senior CMC Regulatory Sciences Specialist (Commercial Submissions) to join our dynamic CMC Regulatory Sciences ... play a critical role in overseeing the Chemistry, Manufacturing, and Controls ( CMC ) aspects of commercial submissions, ensuring compliance with US and ex-US… more
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