Head, Regulatory Affairs, General Medicine and Vaccines

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Head, Regulatory Affairs, General Medicine and Vaccines Canada

As the Head, Regulatory Affairs, General Medicine and Vaccines Canada on our GRA NA team, you’ll be fully accountable to provide leadership to a team of regulatory professionals for regulatory affairs activities including early approvals and regulatory compliance activities throughout the entire product lifecycle for a portfolio of development and marketed prescription products. Ready to get started?

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

The primary purpose of this position is to provide leadership to a team of regulatory professionals for regulatory affairs activities including early approvals and regulatory compliance activities throughout the entire product lifecycle for a portfolio of development and marketed prescription products, as defined by Head, Regulatory Affairs.

This position may also be a designated back-up to the Head, Regulatory Affairs.

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

The Canada Regulatory Affairs team is responsible for preparing and submitting regulatory dossiers to Health Canada to ensure regulatory compliance and obtain marketing authorizations for Sanofi’s General Medicine, Specialty Care, and Vaccine portfolio products. The team serves as the direct point of contact with Health Canada, coordinating regulatory submissions, responding to authority questions, and maintaining commitments to support timely product approvals.

1. Accountable for the activities of a team of professional level individuals, that cover a portfolio (as defined by Head, Regulatory Affairs) of development and marketed products –80-90% of allocated time

• Provide leadership and managerial support to submissions teams to ensure quality decisions and timely preparation of submissions to Health Canada in order to achieve the shortest time to approval and the best possible labelling. The portfolio supports products in the General Medicine and Vaccines Business units.
• Ensure team maintains compliance (as per Global Regulatory Affairs performance timelines) to provision of current and accurate data in internal database systems
• Evaluate business development opportunities in order to assess optimal regulatory strategy
• Provide strategic direction and leadership in the management of clinical trial regulatory activities for defined portfolio
• Participate in Business Unit (as assigned by Head, Regulatory Affairs) cross-functional leadership team(s) to ensure strategic leadership and contribution from regulatory affairs to core business activities
• As part of RA Leadership team, assist Head, Regulatory Affairs in setting strategic direction for team and ensuring smooth daily operations
• Regulatory Resources
• Ensure and maintain visibility and excellence of the team within business units by developing good scientific skills in the core therapeutic areas
• Maintain awareness and knowledge of new and emerging local and international (EU and US) regulatory trends as well as on basic regulatory quality Canadian requirements
• Review and provide comments on Health Canada draft guidelines and policies.

• Ensure implementation of departmental vision and strategies into individual priorities and goals
• Provide constructive feedback and coaching to all direct reports on an ongoing basis to facilitate and enable the attainment of employees’ development plans
• Complete performance review activities for all direct reports as per the established corporate guidelines and practices

Elaborate and…