Senior Manager Regulatory Affairs
Core
Develop globally aligned regulatory strategies for Canadian projects, managing submissions to Health Canada and ensuring compliance with local standards.
Role type
Senior Manager, Regulatory Affairs
Builds
Regulatory strategies, marketing applications, clinical trial submissions, and post-approval documentation for Health Canada.
Domain
Life Sciences / Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory strategy development, Health Canada submission management, clinical trial application leadership, New Drug Submission expertise, post-market submission management, local labelling development, promotional material review, regulatory compliance monitoring, cross-functional collaboration.
Preferred skills
Advanced degree, bilingualism (French and English), strategic thinking, clinical advice capability.
Technologies
Health Canada submission systems, regulatory databases.
Responsibilities
Serve as primary Canadian authority contact, manage timely Health Canada submissions, develop globally aligned regulatory strategies, represent Regulatory Affairs on cross-functional teams, ensure compliance with Canadian standards, develop local labelling and patient information, support Drug Establishment License activities.
Seniority
Senior Manager, hands-on leadership