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.
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