Elevate your career with Fusion Pharmaceuticals as a CMC Regulatory Affairs Lead. This role involves managing regulatory submissions, ensuring compliance across programs while collaborating with cross-functional stakeholders.

As a pivotal member of the CMC team, you will execute and coordinate regulatory activities for innovative oncology programs. This position demands expertise in regulatory systems and document management, with a focus on high-quality submission deadlines.

Solid organizational skills and keen attention to detail are essential for this hands-on role.

Key Responsibilities:

- Coordinate CMC regulatory submission activities across multiple programs
- Author and develop complex regulatory documents clearly
- Track document development and ensure submission readiness




- Maintain CMC regulatory submission trackers and timelines
- Support responses to health authority inquiries

Requirements:

- Bachelor’s degree in a scientific or regulatory discipline
- Experience in CMC regulatory affairs, preferably in pharmaceuticals
- Strong understanding of regulatory submission processes
- Exceptional organizational and project coordination skills
- Ability to manage multiple concurrent deliverables

Be the driving force behind regulatory excellence at Fusion Pharmaceuticals, ensuring all submissions are timely and compliant.

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📌 CMC Regulatory Affairs Lead at Fusion Pharmaceuticals (Canada)
🏢 AstraZeneca
📍 Canada