ProjectLeader,Regulatory

**Reference Number:****R2851035** **Position title****: **Project Leader, Regulatory **Department: **Market Portfolio Strategy Management **Location:** Toronto, ON **About the job** 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. _**Our Team/ Overview:**_ 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. **About Sanofi** 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. ** _Main Responsibilities:_ ** * Provide regulatory strategic and operational input to local and global teams for development and marketed products throughout their lifecycle * Develop and execute filing strategies, including assessing and summarizing scientific and clinical information, where applicable * Organize and coordinate meetings with Health Canada * Ensure the preparation of high-quality regulatory submissions in alignment with internally defined strategies to meet agreed upon timelines and in compliance with Health Canada Regulations * Participate in cross-functional meetings with internal stakeholders (locally and globally), providing subject matter expert input on product strategies * Ensure the ongoing compliance for marketed