Lead CMC Regulatory Strategies at Sanofi (Toronto)

Lead CMC Regulatory Strategies at Sanofi (Toronto)

16 Sep
|
Sanofi
|
Toronto

16 Sep

Sanofi

Toronto

Join Sanofi in Toronto as a Lead for CMC regulatory strategies in vaccine projects for 12 months. Your expertise will support crucial interactions with Health Authorities. As the GRA CMC Lead, you'll oversee various regulatory projects, ensuring compliance and assessing risks effectively.

Your role entails the development of CMC regulatory strategies in collaboration with Global Regulatory Affairs and incident management for timely responses to Health Authorities. Your strategic insight will play a vital role in negotiations and submissions. Key Responsibilities:

- Define CMC regulatory strategies and assess risks
- Ensure collaboration among CMC teams
- Build and maintain relationships with Health Authorities
- Support negotiation processes with regulatory bodies
- Manage CMC regulatory files and variations

Requirements:

- Bachelor's degree in life sciences or related field
- Over 4 years of regulatory experience preferred
- Knowledge of global regulations and guidelines
- Proven ability to solve regulatory issues
- Experience in a large organization’s CMC department is a plus

Contribute to advancing healthcare by leading CMC initiatives at Sanofi.

📌 Lead CMC Regulatory Strategies at Sanofi (Toronto)
🏢 Sanofi
📍 Toronto

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