Manager, Regulatory Affairs
Core
Lead regulatory strategies and submissions for assigned drug and biologic product portfolios to Health Canada.
Role type
Manager, Regulatory Affairs (Pharmaceuticals)
Builds
Regulatory submissions (NDS/SNDS/NC/Level III AN/YBPRs, CTA, CTA-Amendment, CTA-Notification), Drug Establishment License maintenance, and commercial/medical material reviews.
Domain
Pharmaceuticals, Regulatory Affairs, Health Canada
Required skills
Regulatory strategy development, Health Canada liaison, CTD format expertise, clinical trial submission management, SOP development, intelligence monitoring, policy/guidance review, project management, cross-functional collaboration.
Preferred skills
AI tool utilization within regulatory activities, advanced degree (MSc/PhD) or post-graduate certification in Regulatory Affairs.
Technologies
Health Canada submission systems, AI tools for regulatory projects.
Responsibilities
Manage regulatory activities for product portfolios, liaise with global regulatory teams, prepare and submit regulatory filings, coordinate Drug Establishment License maintenance, review commercial/medical materials, conduct intelligence monitoring, develop/maintain SOPs.
Seniority
Manager, hands-on IC