As a GRA CMC Lead, you will manage a portfolio of vaccine projects and marketed products, driving global regulatory CMC strategies and maintaining strong relationships with Health Authorities
Job Summary
As a GRA CMC Lead, you will manage a portfolio of vaccine projects and marketed products, driving global regulatory CMC strategies and maintaining strong relationships with Health Authorities.
Sanofi offers a supportive, future-focused team environment with opportunities for career growth, comprehensive health and wellbeing benefits, and a commitment to diversity and inclusion.
The role involves collaboration across multiple internal departments and external partners to ensure regulatory compliance and successful product lifecycle management.
Matching Summary
As a GRA CMC Lead, you will manage a portfolio of vaccine projects and marketed products, driving global regulatory CMC strategies and maintaining strong relationships with Health Authorities.
Salary
Base: $122,250.00 - $176,583.33; Bonus/Equity: Not specified; Benefits: Company employee benefit programs available
Skills & Requirements
Must-have
Global CMC regulatory strategy
Health Authority interactions
Portfolio management of vaccine projects
Regulatory submission coordination
Change control assessment
Post-approval commitment management
Nice-to-have
Cross-functional collaboration
Strategic negotiation support
Regulatory inspection support
AI-powered research environment
Diversity and inclusion focus
Key Requirements
At least 4 years regulatory experience
Experience in Regulatory CMC department
Knowledge of global regulations and Health Authorities