Project Leader, Regulatory
About The Position
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 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.
Requirements
- BSc. (required), or a degree in a health-related field
- Minimum of 2-3 years of experience in Regulatory Affairs
- Demonstrated success in a regulatory environment (e.g., leading a major submission)
- Good knowledge of the current Health Canada regulations and PAAB guidelines
- Developed change leadership skills (i.e., ability to cope with and adapt to change, effectively prioritize, and deal with ambiguity)
- Strong strategic and operational thinking (i.e., able to think big picture balanced with strong analytical skills)
- Able to manage and influence key stakeholders
- Fosters innovation (i.e., embraces new insights, concepts, trends & processes)
- Works well independently as well as in a group environment
- English (written and spoken)
- MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat
Nice To Haves
- French is an asset
- Veeva Vault database familiarity is an asset
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 products, specifically through product monograph and label updates/revisions
- Review and approve promotional and non-promotional material in accordance with regulatory requirements
- Maintenance of internal databases in timely manner as required for portfolio of products
Benefits
- high-quality healthcare
- prevention and wellness programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
