Senior Manager Regulatory Affairs

Regeneron Canada Company; Toronto; Hybrid; CAD 110.000 - 150.000; Vollzeit

Zusammenfassung

Regeneron Canada Company in Toronto, hybrid role for a Senior Manager, Regulatory Affairs to drive globally aligned regulatory strategies across product development and Canada-specific submissions. You will lead Health Canada interactions, oversee clinical trial applications and post-market submissions, and collaborate with global regulatory and product teams to ensure compliance and successful launches.

The role requires strong leadership, strategic thinking, excellent communication, and the

Qualifikationen

• 6–8 years regulatory experience leading submissions and obtaining clinical trial applications, New Drug Submissions and post-market submissions.
• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory submissions

Health Canada

Cross-functional collaboration

Regulatory strategy

French-English bilingualism

Ausbildung

Bachelor's degree in science

Advanced degree preferred

Jobbeschreibung

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 fast-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.
• 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

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
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

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. For jobs in Canada: this posting is for an existing position.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious 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. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.