Senior Director, CMC Regulatory Affairs, Oncology

Join Moderna, a pioneering team that's revolutionizing medicine through mRNA technology, as a Senior Director, CMC Regulatory Affairs, Oncology. Lead regulatory CMC strategies for oncology submissions, manage a team of experts, and drive regulatory excellence in support of Moderna’s mission to transform patients’ lives through mRNA technology.

Requirements

• Lead development and execution of regulatory CMC strategies for oncology submissions
• Oversee a team of regulatory professionals
• Serve as the key CMC regulatory contact in cross-functional governance forums
• Provide strategic guidance to manufacturing and quality teams
• Lead preparation and review of agency correspondence
• Champion cross-functional initiatives to simplify and enhance business processes
• Mentor, develop, and inspire regulatory professionals
• Act as primary liaison for Regulatory CMC interactions with health authorities
• Support creation and refinement of global CMC templates and knowledge assets

Benefits

• Best-in-class healthcare coverage
• Holistic approach to well-being
• Family planning benefits
• Generous paid time off
• Savings and investment opportunities