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
Senior Regulatory Affairs Manager (Pharmaceuticals)
Builds
Regulatory strategies and submissions for new drug products and line extensions
Domain
Pharmaceuticals / Healthcare
Required skills
Regulatory strategy planning, Health Canada interactions, document review (SOPs, protocols, reports), risk identification and mitigation, compliance monitoring, promotional material review
Preferred skills
Master's degree in a relevant scientific field, experience in a therapeutic area
Technologies
None stated
Responsibilities
Represent Canada on global regulatory teams, collaborate with cross-functional teams to develop regulatory strategies, manage preparation and filing of submissions with Health Canada, review clinical and nonclinical documents, coordinate submission meetings with Health Canada, ensure compliance with Health Canada requirements and corporate policies, communicate regulatory updates to stakeholders, review promotional materials for compliance
Seniority
Senior, hands-on IC