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 risksManage variation approvals, questions,



and regulatory filesCoordinate submissions and post-approval commitment managementSupport negotiations with FDA and EMA Health AuthoritiesResolve CMC regulatory issues and support inspectionsRequirements:
Relevant BS or BA scientific degree requiredAdvanced scientific degree preferredAt least four years’ regulatory experienceGlobal regulations and Health Authority knowledgeEffective communication with internal and external partnersBring 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 (Winnipeg)
🏢 Sanofi Group
📍 Winnipeg