Chef(fe), Réglementation/ Manager, Regulatory Affairs
Core
Responsible for the registration of new products/line extensions/claims in Canada, ensuring regulatory compliance and supporting commercial activities.
Role type
Manager, Regulatory Affairs (Pharmaceutical)
Builds
Regulatory strategies and submissions for new products and line extensions to Health Canada
Domain
Pharmaceutical industry, Drug Development, Canadian Regulatory Affairs
Required skills
Negotiation, Health Canada relationship management, Drug development process knowledge, Scientific principles (chemistry, toxicology, pharmacology, statistics), Medical principles, Business knowledge, Computer skills
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/safety/manufacturing documents, Coordinate submission meetings with Health Canada, Ensure compliance with Health Canada requirements, Communicate regulatory updates, Review promotional materials for compliance
Seniority
Manager, hands-on IC