Take the lead in Regulatory Affairs at a prominent biopharmaceutical company in Canada. Drive the regulatory strategy for oncology and collaborate globally to ensure compliance and successful outcomes.
Reporting to the Vice-President & General Manager, you will provide hands-on leadership and strategic direction in regulatory affairs. This role involves overseeing the full product lifecycle, managing submissions, and interacting with Health Canada. Your expertise will be crucial for maintaining alignment between Canadian and global regulatory frameworks.
Key Responsibilities:
• Lead development of Canadian regulatory strategies for oncology programs
• Ensure compliance of regulatory submissions with Canadian standards
• Serve as primary contact with Health Canada for approvals
• Oversee Scientific Advice Briefing Packages and regulatory applications
• Provide input into clinical trial design and labelling strategies
Requirements:
• 12+ years in Regulatory Affairs within pharma or biotech
• Solid experience in oncology drug development
• Deep understanding of Canadian regulatory frameworks
• Proven success in Health Canada submissions
• Excellent communication and relationship management skills
Lead innovative regulatory strategies and engage with cross-functional teams to drive market success.
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📌 Head of Regulatory Affairs in Canada (Ontario)
🏢 MedAccess Recruiters
📍 Ontario
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