Regulatory Affairs Project Leader, Chemistry, Manufacturing & Controls (CMC)

Reference no. R2849342
Position title: Regulatory Affairs Project Leader, Chemistry, Manufacturing & Controls (CMC)
Location: Toronto, ON

About the job

Join the engine of Sanofi’s mission — where deepimmunosciencemeets bold, AI-powered research. In R&D,you’lldrive breakthroughs that could turn the impossible into possible for millions.

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:

• Accountable for all Regulatory CMC activities related to marketed and development products.

•   Collaborate with Sanofi Global Regulatory Affairs (GRA) teams and external partners to manage regulatory strategies, filings and approvals to meet local & global objectives.

• Submission Lead for all CMC aspects of the submission dossier and local regulatory documents, for the filing of initial New Drug Submissions, all levels of post-Notice of Compliance quality changes submissions, Yearly Biologic Product Reports, and response to Health Canada questions, where applicable.

• Contribute to the preparation of pre-submission packages.

• Participate in Sanofi GRA teams and tasks forces.

• Build rapport with internal stakeholders & Health Canada representatives. Liaise with Canadian Regulatory Authorities.

• Provide comments on draft Health Canada (for prescription drugs, biological drugs and medical devices) and ICH policies and guidances.

• Maintain sound knowledge of Canadian and foreign regulations and policies/guidelines, and keep abreast of scientific developments in key CMC areas.

• Provide scientific and regulatory assessment for the evaluation of new business opportunities, and provide CMC advice on patents.

• Maintenance of internal databases in a timely manner as required for the portfolio of products.

About You

Education

•   BSc. (required), or a degree in Pharmacy or a health-related specialty

Experience

• 2-5 years of combined experience in the pharmaceutical industry: Production, Quality Assurance, Quality Control, Regulatory Affairs

Competencies:

• Demonstrated success in a regulatory environment (e.g., leading a major submission).

• Strong knowledge of CMC regulations and guidelines from Health Canada and ICH; good knowledge of other regional regulatory environments (e.g., FDA, EMA).

• Solid understanding of manufacturing processes and characteristics of various drug dosage forms; good knowledge of drug development phases; good knowledge of bioequivalence principles.

• 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:

• Fluency in spoken and written business English. (highly regarded)

• French is an asset

Computer Knowledge:

• MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat

• Veeva Vault database familiarity is an asset

Travel Requirements:

• This position may require occasional travel

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.

Applications received after the official close date will be reviewed on an individual basis.​ 

This position is for a new 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.