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 cutting-edge oncology programs. This position demands expertise in regulatory systems and document management, with a focus on high-quality submission deadlines. Strong 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 (Hamilton)
🏢 AstraZeneca
📍 Hamilton