Associate Director, Global Regulatory Science, CMC

Role: Associate Director, Global Regulatory Affairs, CMC at Moderna, leading regulatory strategies and submissions for biologics across multiple therapeutic areas, including vaccines, oncology, and rare diseases. Responsibilities: develop and execute international CMC regulatory plans (e.g., IND/CTA/BLA/MAA), oversee agency communications, review and ensure submission readiness, lead regulatory interactions, and support CMC changes and process development. Requirements: BS in Pharmaceutics, Chemistry, or related field; 10+ years pharma/biotech experience, with 8+ years in biologics-focused CMC regulatory roles; strong knowledge of EU and ROW regulations, GxP, CTD formatting, and regulatory compliance. Preferred: MS degree, experience across diverse therapeutic areas, and expertise in regulatory submissions for biologics. High-Value: biologics, vaccines, oncology, rare disease development stages, regulatory agency collaboration, GxP compliance, and cross-functional guidance for manufacturing and quality teams. Work setup: hybrid in-office model with a focus on fast-paced, results-driven environment.