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. 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 inquiriesRequirements:
Bachelor’s degree in a scientific or regulatory discipline
Experience in CMC regulatory affairs, preferably in pharmaceuticals
Solid understanding of regulatory submission processes
Exceptional organizational and project coordination skills
Ability to manage multiple concurrent deliverablesBe the driving force behind regulatory excellence at Fusion Pharmaceuticals, ensuring all submissions are timely and compliant.#J-18808-Ljbffr
📌 Cmc Regulatory Affairs Lead At Fusion Pharmaceuticals Hamilton (Canada)
🏢 AstraZeneca
📍 Canada
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