Elevate your career as the GRA CMC Lead at Sanofi in Toronto, Ontario. In this key role, you’ll manage regulatory strategies for vaccines and directly engage with Health Authorities. The GRA CMC Lead within the R&D; team plays a crucial role in overseeing the CMC regulatory strategy and ensuring smooth collaboration across various departments.

You will be the point of contact with Global Regulatory Affairs, local regulatory teams, and quality groups, focusing on successful project execution and compliance.

Experience in managing regulatory affairs and a strong command of the pharmaceutical industry landscape is essential. Key Responsibilities:

- Develop CMC regulatory strategies for new and marketed products
- Foster collaboration within CMC teams on regulatory matters




- Manage interactions with Health Authorities effectively
- Draft documents for submission and negotiations with authorities
- Coordinate submission of regulatory files and ensure compliance

Requirements:

- BS/BA in a relevant scientific discipline
- 4+ years in a regulatory role in pharmaceuticals
- Solid knowledge of global regulations and guidelines
- Strong communication skills for regulatory partnerships
- Ability to analyze risks and develop strategic solutions

Harness your expertise in regulatory affairs to support Sanofi's mission in delivering cutting-edge healthcare solutions.

📌 GRA CMC Lead at Sanofi Toronto
🏢 Sanofi
📍 Toronto