Reference No. R2725558

　　Position Title: Project Leader, Regulatory Chemistry, Manufacturing & Controls (CMC)

　　Duration: Fixed-Term - Contract End Date: December 31, 2025

　　Department: Regulatory CMC

　　Location: Toronto Campus, Ontario

　　About Sanofi - www.sanofi.ca

　　At Sanofi, we chase the miracles of science to improve people's lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

　　As one of Canada's leading investors in life sciences, manufacturing and research and development, we focus on delivering new and better ways to address unmet medical needs. Our life-changing and lifesaving products are grounded in science that Canadians can trust. They empower self-care, prevent and treat diseases, and help people live better.

　　Sanofi Canada operations focus on four therapeutic areas: General Medicines(diabetes, cardiovascular, arthritis, transplant, and thyroid cancer); Specialty Care(rare diseases, rare blood disorders, oncology, immunology, multiple sclerosis); Vaccines(manufactures, formulates, fills, inspects and/or packages vaccines and biologics, protecting against 20 infectious diseases including pertussis, diphtheria, tetanus and influenza); and Consumer Healthcare(pain care, allergy, digestive health, personal care).

　　Position Summary:

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

　　Key Responsibilities:

　　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 timely manner as required for portfolio of products.

　　Key Requirements:

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

　　5-10 years of combined experience in the pharmaceutical industry: Production, Quality Assurance, Quality Control, Regulatory Affairs

　　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 environment (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:

　　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

　　Pursue Progress.

　　Discover Extraordinary

　　Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

　　Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!

　　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.

　　Thank you in advance for your interest.

　　Only those candidates selected for interviews will be contacted.

　　Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi

　　#GD-SA #LI-SA

　　At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.