Regulatory Program Director at Roche
22 hours ago
Mississauga, Ontario, Canada
F. Hoffmann-La Roche AG
Full-time
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Shape innovative healthcare solutions as an Associate Regulatory Program Director at Roche in Mississauga. Ensure compliance and quality in global CMC regulatory submissions while driving strategic initiatives.
This pivotal role requires a Bachelor’s Degree in life sciences and at least five years of technical regulatory CMC experience. You will develop robust regulatory strategies and interact with Health Authorities globally, emphasizing compliance with cGMP standards and Roche corporate protocols.
Key Responsibilities
• Manage high-quality CMC regulatory submissions globally
• Develop and execute regulatory strategies
• Ensure data accuracy in regulatory documents
• Analyze regulatory risks and opportunities
• Oversee timely responses to Health Authority inquiries
Requirements:
• Bachelor’s Degree in life science disciplines
• Minimum 5 years of industry experience in regulatory CMC
• Proficiency with global Health Authority guidelines
• Technical understanding of drug manufacturing processes
• General awareness of drug development and commercialization Influence the future of healthcare through regulatory excellence at Roche in Mississauga.
Key Responsibilities
• Manage high-quality CMC regulatory submissions globally
• Develop and execute regulatory strategies
• Ensure data accuracy in regulatory documents
• Analyze regulatory risks and opportunities
• Oversee timely responses to Health Authority inquiries
Requirements:
• Bachelor’s Degree in life science disciplines
• Minimum 5 years of industry experience in regulatory CMC
• Proficiency with global Health Authority guidelines
• Technical understanding of drug manufacturing processes
• General awareness of drug development and commercialization Influence the future of healthcare through regulatory excellence at Roche in Mississauga.