GRA CMC Regulatory Lead in R&D (Toronto)

GRA CMC Regulatory Lead in R&D (Toronto)

17 Sep
|
Biopharma Careers
|
Toronto

17 Sep

Biopharma Careers

Toronto

Join Sanofi in Toronto as the GRA CMC Lead, focusing on the energetic role of developing CMC regulatory strategies for critical vaccine projects. This fixed-term role spans 12 months. As the GRA CMC Lead, you will be integral to R&D; efforts, overseeing regulatory strategies pertinent to new and existing vaccine products.

You will engage with global Health Authorities and work in tandem with various internal teams to negotiate and ensure compliance with regulatory submissions while addressing potential challenges effectively. Key Responsibilities:

- Create and implement CMC regulatory strategies
- Engage in comprehensive Change Control evaluations
- Encourage cohesive efforts within CMC teams
- Address and manage Health Authority requests promptly
- Oversee regulatory submission preparation and review Requirements:
- At least 4 years of regulatory experience, preferably in pharmaceuticals
- Relevant Bachelor's degree required
- Knowledge of international regulations and Health Authority processes
- Effective communication and initiative in problem resolution
- Proven ability to work collaboratively across functions Bring your strategic insight and regulatory expertise to enhance Sanofi’s innovative vaccine programs.

📌 GRA CMC Regulatory Lead in R&D (Toronto)
🏢 Biopharma Careers
📍 Toronto

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