Toronto GRA CMC Lead - Vaccine Regulations
Eacademy Sanofi • toronto, Canada
Role Description
Become a pivotal GRA CMC Lead at Sanofi in Toronto, specializing in vaccine regulatory compliance. Influence critical regulatory strategies and engage with health authorities.
In this essential role, you will manage a portfolio of diverse vaccine-related projects within the GRA Regulatory CMC & Devices department. As a GRA CMC Lead, you will navigate the complexities of compliance and strategic negotiations with health authorities like the FDA and EMA, ensuring Sanofi's vaccine projects meet all requirements. Your leadership will aid in forging strong collaborations across departments, enhancing the regulatory landscape for innovative healthcare solutions.
Key Responsibilities:
• Develop and implement CMC regulatory strategies
• Ensure timely responses for regulatory inquiries
• Document and support health authority submissions
• Manage change control and project risks effectively
• Coordinate CMC regulatory files post-approval
Requirements:
• 4+ years of exp...
In this essential role, you will manage a portfolio of diverse vaccine-related projects within the GRA Regulatory CMC & Devices department. As a GRA CMC Lead, you will navigate the complexities of compliance and strategic negotiations with health authorities like the FDA and EMA, ensuring Sanofi's vaccine projects meet all requirements. Your leadership will aid in forging strong collaborations across departments, enhancing the regulatory landscape for innovative healthcare solutions.
Key Responsibilities:
• Develop and implement CMC regulatory strategies
• Ensure timely responses for regulatory inquiries
• Document and support health authority submissions
• Manage change control and project risks effectively
• Coordinate CMC regulatory files post-approval
Requirements:
• 4+ years of exp...