Lead global CMC regulatory strategy for Sanofi vaccines in Toronto, using regulatory expertise and Health Authority engagement across projects and products.
As GRA CMC Lead within Sanofi’s R&D; team, you will manage a portfolio of development projects and marketed products. You will define global CMC regulatory strategies, manage variation approvals and questions, and interact directly with Health Authorities. Collaboration spans Global and Regional Regulatory Affairs, local regulatory teams, quality groups, R&D;, Industrial Affairs, and RSO teams. You will also work with partners, Human Resources, Legal Services, and Finance.
Key Responsibilities: Develop CMC strategies and assess regulatory risks
Manage variation approvals, questions, and regulatory files




Coordinate submissions and post-approval commitment management
Support negotiations with FDA and EMA Health Authorities
Resolve CMC regulatory issues and support inspections
Requirements: Relevant BS or BA scientific degree required
Advanced scientific degree preferred
At least four years’ regulatory experience
Global regulations and Health Authority knowledge
Effective communication with internal and external partners
Bring global CMC strategy, submission coordination, and Health Authority expertise to Sanofi’s vaccine regulatory team in Toronto.

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📌 Global CMC Regulatory Lead Vaccines (Ontario)
🏢 Sanofi Group
📍 Ontario