Senior Manager Regulatory Affairs (Winnipeg)

Senior Manager Regulatory Affairs (Winnipeg)

08 Nov
|
Regeneron Pharmaceuticals
|
Winnipeg

08 Nov

Regeneron Pharmaceuticals

Winnipeg

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 andnon-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, Recent Drug Submission and post-market submission approvals.

Strategic thinking and clinical advice based on local requirements. French and English bilingualism is an asset. We are committed to building a workplace with an inclusive culture.



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. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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 offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.G. medical, dental, vision, life and disability), paid time off, and family support benefits.

📌 Senior Manager Regulatory Affairs (Winnipeg)
🏢 Regeneron Pharmaceuticals
📍 Winnipeg

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