Project Leader, 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’rean 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 / Knowledge:

• 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

Disclaimer

The above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.