CMC Submissions and Information Management Lead

Start free →

Or apply yourself on the official page →

About the role

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next generation radioconjugates (RCs) as precision medicines. Fusion has multiple pipeline programs entering early FIH trials. In addition, Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support execution for these programs, Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radioconjugate manufacturing facility to meet the demand for our growing pipeline of RCs. Introduction to the Role : The CMC Regulatory Affairs, Submissions & Operations role is responsible for the hands-on execution and coordination of CMC regulatory activities across assigned programs. This role reports into the Associate Director, CMC Regulatory Affairs and partners closely with cross-functional stakeholders to ensure regulatory deliverables are developed, reviewed, tracked, and submitted accurately and on time. The role is highly execution-focused and requires strong organizational skills, attention to detail, regulatory knowledge, and the ability to manage multiple concurrent deliverables. The successful candidate will be comfortable working within regulatory systems and submission processes while maintaining a strong understanding of the broader CMC regulatory objectives of each program. Key Responsibilities Regulatory Submission Execution • Coordinate and execute CMC regulatory submission activities across development and commercial programs. • Lead the development and authoring of complex CMC regulatory documents and submission content. • Translate complex CMC and scientific information into clear, concise, scientifically sound regulatory narratives. • Support preparation and compilation of CMC content for IND/CTA, NDA/BLA/MAA, supplements/variations, annual reports, and other regulatory submissions as applicable. • Coordinate submission deliverables across CMC, Quality, Manufacturing, Analytical, Regulatory, and other functional teams. • Track document development, review cycles, approvals, and submission readiness. • Ensure CMC regulatory documents are completed according to established timelines and quality standards. • Support responses to health authority questions and requests for information. Regulatory Systems & Submission Operations • Execute activities within the Enterprise Regulatory Vault (ERV) and other applicable regulatory systems. • Maintain accurate submission records, metadata, document status, and regulatory correspondence. • Coordinate document filing and archival activities in accordance with applicable processes. • Support publishing, submission assembly, document formatting, and technical submission requirements. • Ensure regulatory information and documentation remain accurate, current, and inspection-ready. • Responsibility for change management as assigned • Understands application of appropriate risk management across own activities Project & Workflow Management • Maintain CMC regulatory submission trackers, timelines, action logs, and deliverable plans. • Proactively identify upcoming milestones, dependencies, and potential delays. • Coordinate meetings, agendas, actions, and follow-up activities related to CMC regulatory deliverables. • Escalate risks and issues to the Associate Director, CMC Regulatory Affairs or functional lead. • Support multiple programs and submissions simultaneously while effectively prioritizing competing deadlines. CMC Regulatory Content Support • Draft, Author, Review CMC regulatory documents for completeness, consistency, formatting, and alignment with submission requirements. • Support preparati

View the official posting →