Join Regeneron as a Senior Manager in Regulatory Affairs, based in Toronto with a hybrid work model. You'll navigate regulatory strategies and ensure compliance while driving impactful pharmaceutical projects.
In this senior role, you will lead regulatory affairs for Canadian projects, collaborating closely with global teams. You will manage submissions to Health Canada and contribute to the development of regulatory strategies throughout product lifecycles. Your strategic insights and communication skills will play a pivotal role in this quick-growing, science-driven organization.
Key Responsibilities:
• Serve as the primary Canadian authority contact for assigned projects
• Manage Health Canada clinical trial and marketing application submissions
• Develop regulatory strategies aligned with global standards
• Represent Regulatory Affairs in cross-functional teams
• Ensure compliance with Canadian regulations and local standards
Requirements:
• Bachelor's degree in a scientific field; advanced degree preferred
• 6-8 years of regulatory experience in submissions and approvals
• Proven leadership in Health Canada meetings and product launches
• Strong problem-solving and prioritization skills
• Bilingual in French and English is an asset
Lead regulatory strategies that impact patients worldwide at Regeneron in Toronto.
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