Regulatory Affairs Manager

Key Responsibilities

• Lead and execute Canadian regulatory activities across clinical development and marketed products, ensuring compliance with Health Canada requirements
• Prepare, review, and submit clinical and lifecycle regulatory filings, including variations, labeling updates, and post-approval submissions for innovative drugs
• Serve as a primary regulatory contact for Health Canada interactions, managing questions, clarifications, and follow-up during review cycles
• Provide regulatory guidance and oversight to supporting regulatory resources to ensure high-quality, timely deliverables
• Collaborate with cross-functional stakeholders including Clinical, Medical, Quality, CMC, and Global Regulatory teams to align regulatory strategy and execution
• Review promotional and non-promotional materials to ensure regulatory compliance and consistency with approved labeling
• Maintain accurate regulatory documentation and records within internal systems in accordance with SOPs and regulatory standards
• Support continuous improvement of regulatory processes and ways of working