Chef(fe), Réglementation/ Manager, Regulatory Affairs
Core
Responsible for the registration of new products, line extensions, and claims in Canada, ensuring regulatory compliance and supporting commercial activities.
Role type
Manager, Regulatory Affairs (Pharmaceutical)
Builds
Regulatory strategies and high-quality submissions for Health Canada to secure timely product approvals.
Domain
Pharmaceutical industry, Canadian regulatory affairs
Required skills
Negotiation with regulatory agencies, knowledge of Food and Drug Act and Health Canada policies, scientific principles (chemistry, toxicology, pharmacology, statistics), drug development process knowledge, medical principles, business knowledge, computer skills, English and French proficiency
Preferred skills
Master's degree (M.Sc.)
Technologies
None stated
Responsibilities
Represent Canada on Global Regulatory Teams, collaborate with cross-functional teams to develop regulatory strategies, identify and communicate risks, manage preparation and filing with Health Canada, review clinical and nonclinical documents, coordinate submission meetings, ensure compliance with regulations and internal processes, review promotional materials
Seniority
Manager, hands-on IC