Head, Regulatory Affairs, General Medicine and Vaccines Canada
Core
Provide leadership to a team of regulatory professionals for regulatory affairs activities including early approvals and regulatory compliance throughout the product lifecycle for General Medicine and Vaccines portfolios.
Role type
Senior IC regulatory affairs leader (Head of Regulatory Affairs)
Builds
Regulatory dossiers and submissions to Health Canada for marketing authorizations
Domain
Biopharma, General Medicine, Vaccines
Deliverable
client delivery
Required skills
Leadership and managerial skills, strategic thinking, negotiation skills, risk analysis, project management, change leadership
Preferred skills
Knowledge of EU and US regulatory trends, familiarity with Veeva Vault database
Technologies
MS Office suite, Veeva Vault
Responsibilities
Provide leadership and managerial support to submissions teams for Health Canada submissions, ensure team compliance with global performance timelines, evaluate business development opportunities for optimal regulatory strategy, participate in cross-functional leadership teams, establish and maintain networks with Canadian regulatory authorities and key opinion leaders, review and comment on Health Canada draft guidelines and policies.
Seniority
Senior, hands-on IC with team leadership
