At a Glance
- Tasks: Lead regulatory strategies and manage submissions for life-changing medicines.
- Company: Join Regeneron, a science-driven company making a global impact.
- Benefits: Competitive salary, bonuses, health benefits, and flexible work options.
- Other info: Inclusive culture with opportunities for professional growth.
- Why this job: Make a meaningful difference in patients' lives while advancing your career.
- Qualifications: 6-8 years of regulatory experience and strong communication skills.
The predicted salary is between 99000 - 121000 $ per year.
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.
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.
- 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.
Senior Manager Regulatory Affairs in Mississauga employer: Regeneron Pharmaceuticals, Inc
At Regeneron, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work culture that fosters collaboration and innovation. As a Manager in Medical Affairs Operations based in Mississauga, Canada, you will have the opportunity to contribute to life-changing medicines while enjoying a hybrid work environment, competitive benefits, and ample opportunities for professional growth within a fast-paced, science-driven organization dedicated to making a meaningful impact on patients' lives worldwide.
Contact Details:
Regeneron Pharmaceuticals, Inc Recruitment Team
