Lead CMC Regulatory Strategies at Sanofi (Ontario)

Lead CMC Regulatory Strategies at Sanofi (Ontario)

07 Sep
|
Biopharma Careers
|
Ontario

07 Sep

Biopharma Careers

Ontario

Elevate your career with Sanofi as a GRA CMC Lead in Toronto. Focus on developing CMC regulatory strategies and engaging with global Health Authorities on vaccine projects.

In this pivotal role within R&D;, you will manage project portfolios while collaborating with key stakeholders like Global Regulatory Affairs and site quality teams. Your primary duties will involve overseeing the preparation of regulatory submissions and establishing robust relationships with regulatory bodies to ensure compliance and address challenges efficiently.

Key Responsibilities:
• Design CMC regulatory strategies for recent and marketed products
• Assess Change Control processes effectively
• Strengthen collaboration across CMC teams




• Communicate risks and strategies for major regulatory impacts
• Coordinate submission of CMC regulatory files

Requirements:
• 4+ years' experience in a regulatory capacity in the pharmaceuticals sector
• Bachelor’s in a relevant scientific discipline
• Familiarity with global regulations and Health Authority expectations
• Excellent communication and problem-solving skills
• Ability to foster relationships with internal and external partners

Utilize your regulatory acumen to contribute to Sanofi's mission in transforming health outcomes.
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📌 Lead CMC Regulatory Strategies at Sanofi (Ontario)
🏢 Biopharma Careers
📍 Ontario

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