Build our future together: 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 quick-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where: Toronto (Hybrid) Discover your role: Serve as primary Canadian authority contact, leading meetings for assigned projects.
Manage timely Health Canada clinical trial, marketing application and post-approval submissions.
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.
This role requires: Scientific bachelor’s degree; advanced degree preferred. 6–8 years’ regulatory experience leading submissions and obtaining clinical trial application, New Drug Submission and post-market submission approvals.
Experience leading face-to-face Health Canada meetings and new product launches.
Strategic thinking and clinical advice based on local requirements.
Problem-solving, multitasking and prioritisation abilities.
Excellent verbal, written and interpersonal communication.
Collaboration in an innovation-focused matrix environment.