
R&D
Where your curiosity drives the
miracles of
science
Regulatory Affairs Project Leader
At a glance
Bring your curiosity to a team where deep immunoscience meets cutting-edge innovation. Across oncology, rare diseases, neurology, and vaccines, you’ll work at the intersection of lab science and AI-powered discovery — all while collaborating across boundaries to turn breakthrough ideas into real-world impact. Whether you want to deepen your scientific expertise or grow as a leader, you’ll find the opportunity here.
Reference No. R2824249
Position Title: Regulatory Affairs Project Leader
Department:Regulatory Affairs
Location: Toronto, Ontario
About the Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
Responsible for the Regulatory Affairs (RA) project management of development and marketed products.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
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., or an equivalent degree in a health-related field
EXPERIENCE
Minimum of 2-3 years of experience in Regulatory Affairs
SPECIFIC SKILLS AND/OR 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
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 a current vacant role that we are actively hiring for.
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise. Des informations supplémentaires sur les avantages sociaux peuvent être trouvées ici.
Pursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
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Why work with us
- Expand your horizons. Grow through curiosity, with support to move, learn, and lead in a culture that champions mentorship, mobility, and bold development.
- Accelerate results with technology. Harness the power of AI and automation to push scientific boundaries and reimagine what's possible in drug discovery.
- Impact through inclusive innovation. Help deliver better science and fairer outcomes by driving inclusive research that reaches more people, in more meaningful ways.
- Turn patient needs into breakthrough science. Drive scientific breakthroughs that start with patient needs – and end in treatments that change lives.
Meet Nils Libert, Associate Scientist
Meet Nils Libert, an Associate Scientist in Belgium, where he plays a key role in advancing groundbreaking research. Learn how his work helps drive innovation, uncover new scientific possibilities, and contribute to life-changing treatments that impact patients around the world.

"At Sanofi, we are building an R&D engine powered by the best science, digital innovation, and a commitment to transforming the lives of patients around the world."

Houman Ashrafian
EVP & Head of R&D
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