Senior Regulatory Affairs Lead, Canada (Hybrid)

Regeneron Pharmaceuticals; Toronto; Hybrid; CAD 120,000 - 160,000; Full time

Job summary

Regeneron Pharmaceuticals in Toronto is seeking a Senior Manager, Regulatory Affairs to lead Canadian regulatory submissions in a hybrid work setting. You will develop globally aligned regulatory strategies across product development and collaborate with global teams to advance therapies for patients.

In this role you will serve as the primary Health Canada liaison, manage clinical trial, marketing application and post-approval submissions, and ensure compliance with local labeling, safety and

Qualifications

• 6–8 years regulatory experience leading submissions.
• Experience leading Health Canada meetings and product launches.
• Bilingual French and English is an asset.
• Excellent communication and problem-solving skills.

Responsibilities

• 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 product development stages.
• Represent Regulatory Affairs on cross-functional teams.
• Ensure Canadian regulatory and local standards compliance; monitor Health Canada policy changes and provide comments.
• Develop local labeling and patient information; approve promotional and non-promotional materials.

Skills

Regulatory submissions

Health Canada liaison

Cross-functional collaboration

Strategic regulatory planning

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

Regeneron Pharmaceuticals in Toronto is seeking a Senior Manager, Regulatory Affairs to lead Canadian regulatory submissions in a hybrid work setting. You will develop globally aligned regulatory strategies across product development and collaborate with global teams to advance therapies for patients.

In this role you will serve as the primary Health Canada liaison, manage clinical trial, marketing application and post-approval submissions, and ensure compliance with local labeling, safety and