GRACMCLead

**Job title:** GRA CMC Lead * **Location:** Morristown, NJ **About the Job** As **GRA CMC Lead** within our **R &D team**, you will be responsible for managing a portfolio of projects and/or marketed products. The GRA CMC Lead, Vaccines is responsible for the global CMC regulatory strategy definition, managing variation approvals and questions, as well as direct interactions with Health Authorities. You will work closely with Global Regulatory Affairs (GRA), Regions ("Regional GRA"), local regulatory teams, quality groups within R&D and Industrial Affairs, including in particular the RSO (Regulatory Site Officer) teams, with partners, and also with Human Resources, Legal Services, Finance, and Health Authorities. You will also be involved in internal or external programs/organizations led by Sanofi and ensure representation of the company by demonstrating the values of Sanofi and Global Regulatory Affairs. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. **About Sanofi** We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. **Main Responsibilities** * Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products (new products or marketed products) in collaboration with all Global Regulatory Affairs entities. * Participate in Change Control assessment. * Guarantee strong collaboration within CMC teams for the implementation of defined regulatory strategies. * Ensure that for CMC activities with a major regulatory and/or financial impact, appropriate strategies are imple