Shape the future of drug development with AstraZeneca as a Regulatory Affairs Manager in Canada. This hybrid role focuses on regulatory strategy and portfolio management to enhance efficacy.
The Regulatory Affairs
Manager will support the Associate Director to develop key regulatory approaches. Candidates should possess extensive knowledge of Canadian regulations, with at least five years in regulatory affairs. This position emphasizes teamwork across various departments and strategic communications with Health Canada. Key Responsibilities:
Lead regulatory strategy development for products
Prepare regulatory submissions to Health Canada
Coordinate with local and global teams
Manage Health Canada correspondence and clarifications
Develop and maintain regulatory standard operating procedures Requirements:
5+ years in Regulatory Affairs with drugs/biologics
Advanced understanding of Canadian Food & Drug Regulations
Proficient in AI tools application in regulatory activities
Excellent negotiation and communication skills
Advanced degree preferred in relevant fields Make an impact in regulatory affairs with your expertise at AstraZeneca.