Director of Regulatory Affairs - Oncology Focus

Join a leading biopharmaceutical firm as the Senior Director of Regulatory Affairs in Canada. Shape the regulatory landscape for oncology therapies while collaborating with global teams for optimal results.

In this pivotal role, you'll work closely with the Vice-President & General Manager to establish regulatory strategies through the product lifecycle. Your leadership will ensure compliance and responsiveness to evolving Canadian regulatory requirements. Engage with health authorities to facilitate submissions and approvals effectively.

Key Responsibilities:

• Direct Canadian regulatory strategies across product lifecycle stages

• Manage and execute regulatory submissions to Health Canada

• Compose Scientific Advice Briefing Packages for regulatory requests

• Contribute insights into clinical and market strategies

• Align Canadian strategies with global regulatory teams

Requirements:

• 12+ years of extensive experience in Regulatory Affairs

• Specialized in oncology drug development platforms

• In-depth knowledge of Canadian regulations

• Proven ability in navigating complex regulatory challenges

• Strong presentation skills for cross-functional communication

Deliver impactful regulatory leadership that drives oncology initiatives and satisfies health authority criteria.
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