At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Regulatory Affairs to join our Regulatory Affairs team, supporting our Canadian projects in a hybrid setting. In this role, you will develop globally aligned regulatory strategies throughout product development while collaborating with global regulatory and product teams.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. Serve as primary Canadian authority contact, leading meetings for assigned projects. Develop high-quality, globally aligned regulatory strategies throughout relevant product development stages.

Represent Regulatory

Affairs on cross-functional teams.

Ensure

Canadian regulatory and local standards compliance; monitor Health Canada policy, regulation and guidance changes, providing comments. Develop local labelling and patient information; approve promotional and non-promotional materials against regulatory requirements.

Support Health Canada Drug Establishment

License activities and local/global process development. You bring a collaborative mindset to regulatory challenges. Scientific bachelor’s degree; 6–8 years’ regulatory experience leading submissions and obtaining clinical trial application, New Drug Submission and post-market submission approvals. ~ Strategic thinking and clinical advice based on local requirements. ~ French and English bilingualism is an asset.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof),



sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. annual bonuses or other incentive plans ~ equity awards ~ pension or retirement benefits ~insurance benefits (e.g. medical, dental, vision, life and disability) ~ As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with responsible diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

📌 Senior Manager, Regulatory Affairs (Toronto)
🏢 Regeneron Canada
📍 Toronto