Step into a pivotal role at Alexion as the Regulatory Affairs Manager in Canada. In this position, you will oversee critical regulatory submissions and collaborate with diverse teams, working in a adaptable setting.

This managerial position entails engaging in regulatory strategy development for pharmaceuticals, managing submissions to Health Canada, and working alongside cross-functional teams. Your insights will facilitate compliance with regulations while ensuring timely completion of project deliverables, including the integration of AI tools.

Key Responsibilities:
Lead regulatory activities for key product portfolios
Prepare NDS/SNDS submissions and oversee communications
Ensure timely stakeholder updates on regulatory matters




Collaborate on clinical trial submissions and oversight
Maintain SOPs and conduct regulatory policy reviews

Requirements:
5+ years of experience in pharmaceutical Regulatory Affairs
Robust grasp of Canadian Food & Drug guidelines
Excellent detail orientation and project management
Familiar with AI applications in regulatory settings
Preferred MSc. or PhD. in a relevant field

Drive regulatory success and transformative healthcare projects at Alexion in Canada.
J-18808-Ljbffr

📌 Canada Regulatory Affairs Manager Role Mississauga
🏢 Alexion Pharmaceuticals,Inc.
📍 Mississauga