Regulatory Affairs Project Leader

**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 analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company's Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada's Privacy Officer via Sanofi's data subject request portal, ++Data Subject Rights Webform++. The ++Data Subject Rights Webform++ can also be used to request access or correction of your personal information and file a complaint.

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.

Toute compensation sera déterminée en fonction de l'expérience démontrée. 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.