Regulatory Affairs Project Leader
Core
Lead regulatory affairs projects for development and marketed products, preparing submissions to Health Canada and ensuring compliance for Sanofi's General Medicine, Specialty Care, and Vaccine portfolios.
Role type
Senior Regulatory Affairs Project Leader
Builds
Regulatory dossiers and submissions for Health Canada approval
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
Regulatory project management, Health Canada regulations knowledge, filing strategy development, stakeholder management, cross-functional collaboration, compliance monitoring, promotional material review
Preferred skills
Veeva Vault database familiarity, French language proficiency, change leadership
Technologies
MS Office suite, Veeva Vault
Responsibilities
Develop and execute filing strategies, organize meetings with Health Canada, ensure high-quality regulatory submissions, maintain internal databases, review promotional materials, provide strategic input to global teams
Seniority
Senior, hands-on IC