19 Aug
|
Alexion Pharmaceuticals,Inc.
|
Ontario
19 Aug
Alexion Pharmaceuticals,Inc.
Ontario
Join Alexion as the Regulatory Affairs Manager in Canada, focusing on strategic regulatory activities for pharmaceutical innovations. Enjoy in-person collaboration while shaping the future of drug approval processes.
In this senior role, you will guide regulatory submissions and foster relationships with Health Canada. Your skills will bridge local and global teams, ensuring adherence to Canadian regulations while leveraging innovative AI solutions in your regulatory projects.
Key Responsibilities:
• Manage the regulatory filing process for all portfolios
• Collaborate with global teams on submissions and guidelines
• Conduct regulatory intelligence monitoring and updates
• Review commercial and medical materials promptly
• Develop and uphold Regulatory Affairs Standard Operating Procedures
Requirements:
• At least 5 years in Regulatory Affairs in a pharma setting
• Comprehensive knowledge of drug commercialization processes
• Proven negotiation and influencing skills
• Proficient in CTD format documentation
• B.Sc. in life sciences; advanced degree preferred
Lead regulatory initiatives and strategic planning at Alexion, integrating compliance with cutting-edge healthcare solutions.
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📌 Manager of Regulatory Affairs at Alexion (Ontario)
🏢 Alexion Pharmaceuticals,Inc.
📍 Ontario