# Regulatory Affairs Project Leader at Sanofi

Sanofi is hiring a Regulatory Affairs Project Leader in Toronto, Canada. Level rates it Little AI ●○○○; you can [apply on Sanofi](https://jobsbylevel.com/go/fafaa81c-fe4d-460c-b353-848381f30136?utm_medium=ai-agent).

AI Level 1, AI centrality 35 out of 100. Toronto, ON.

## Details

- Company: [Sanofi](https://jobsbylevel.com/companies/sanofi)
- AI level: AI Level 1 (score 35 out of 100)
- Location: Toronto, ON
- Posted: November 11, 2026
- Apply: https://jobsbylevel.com/go/fafaa81c-fe4d-460c-b353-848381f30136?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=regulatory-affairs-project-leader-at-sanofi-b60444

## Description

Reference no. R2876875 Position title: Regulatory Affairs Project Leader Department: Regulatory Affairs 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. 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. Position Summary: Responsible for the Regulatory Affairs (RA) project management of development and marketed products. 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 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 About you Education: BSc. (required), or a degree in a health-related field Experience: Minimum of 2-3 years of experience in Regulatory Affairs Specific Skills / Competencies: 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 Languages: English (written and spoken) French is an asset Computer knowledge: MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat Veeva Vault database familiarity is an asset Travel: Occasional Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs. This position is for an existing vacant role that is now open for applications. AI Usage "Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/regulatory-affairs-project-leader-at-sanofi-b60444

Source: https://jobsbylevel.com/jobs/regulatory-affairs-project-leader-at-sanofi-b60444

## Cite this page

Level. https://jobsbylevel.com/jobs/regulatory-affairs-project-leader-at-sanofi-b60444.

Get job alerts: https://jobsbylevel.com/newsletter