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 in Toronto employer: Sanofi Group
Sanofi is an exceptional employer that fosters a collaborative and innovative work culture, empowering employees to contribute to life-changing treatments in the heart of Toronto. With a commitment to employee growth, Sanofi offers numerous opportunities for career advancement and a comprehensive rewards package that recognizes individual contributions. Join a diverse team dedicated to chasing the miracles of science while enjoying a supportive environment that prioritizes well-being and professional development.
