Sanofi
Biopharma
GRACMCLead
Neural analysis suggests this role is
optimal for Mid candidates.
“GRA CMC Lead at Sanofi. Skills: CMC regulatory strategy, Health Authority interaction, Regulatory affairs. Develop CMC regulatory strategies. Assess associated risks”
Industry & Context.
Ability to solve strategic technical and regulatory problems
What They're Looking For.
Must Have
At least 4+ years' experience in a regulatory role, Operational experience within an organization (medium to large) in Regulatory CMC department, Knowledge of global regulations/guidelines; Health Authorities, their modes of operation and their expectations, Ability to solve strategic technical and regulatory problems, Demonstrate initiative, reflection, foresight and the ability to communicate effectively with internal or external partners
Nice to Have
Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field)
What You'll Do.
Develop CMC regulatory strategies
Assess associated risks
Participate in Change Control assessment
Guarantee collaboration within CMC teams
Ensure appropriate strategies are implemented
Ensure Health Authority requests are taken into account
Develop lasting relationships with Health Authorities
Provide support for strategic negotiations
Draft supporting documents for consultation
Coordinate submission of CMC regulatory files
Ensure monitoring of post-approval commitments
Ensure variation files are prepared
Author the CMC strategy document
Ensure CMC regulatory issues are resolved
Support the regulatory inspection process
Contribute to Sanofi initiatives
Review local and international regulations
How You'll Work.
Team & Collaboration
Works 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 but also with Human Resources, Legal Services, Finance or Health Authorities.; Collaboration within CMC teams for the implementation of defined regulatory strategies.; Collaboration with all Global Regulatory Affairs entities.
Communication Scope
Ability to communicate effectively with internal or external partners
Process & Methodology
Managing a portfolio of projects
Full Job Description
**Reference no.****R2857578** **Position title:** GRA CMC Lead **Department:** GRA CMC Vaccine Influenza & COVID **Location:** Toronto, ON **About the Job** As a GRA CMC Lead within our GRA Regulatory CMC & Devices (Vaccines), you’ll responsible for managing a portfolio of projects and/or marketed products. Ready to get started? 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. Within the “GRA Regulatory CMC & Devices (Vaccines)” department, the GRA CMC Lead, Vaccines is 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 the Health Authorities. The GRA CMC Lead, Vaccines works 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 but also with Human Resources, Legal Services, Finance or Health Authorities. The GRA CMC Lead, Vaccines is also involved in internal or external programs/organizations leaded by Sanofi and ensures representation of the company by demonstrating the values of Sanofi and Global Regulatory Affairs. **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 p
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