Associate Director, CMC Regulatory Affairs, International
Core
Lead global CMC regulatory strategies and submissions for Moderna's mRNA medicines, ensuring compliance with international health authority requirements.
Role type
Associate Director, CMC Regulatory Affairs
Builds
Regulatory applications (INDs, CTAs, BLAs, MAAs) and CMC submission documentation for global markets
Domain
Biopharmaceuticals / mRNA therapeutics / International Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC regulatory strategy, IND/CTA/BLA/MAA preparation, CTD format expertise, EU and ROW regulations knowledge, Cgmp compliance, change control assessment, cross-functional collaboration, regulatory risk mitigation, therapeutic area expertise (vaccines/oncology/rare diseases), regulatory intelligence
Preferred skills
MS in Pharmaceutics/Chemistry/Chemical Engineering, experience in emerging markets (LATAM), AI-enabled regulatory tools
Technologies
CTD format, AI-enabled regulatory tools
Responsibilities
Develop global CMC regulatory strategies for international submissions, lead preparation and review of CMC agency correspondence, govern CMC submission activities, mitigate regulatory risks, provide strategic guidance to product development teams, lead negotiations with international health authorities, interpret evolving regulatory guidance, support lifecycle management of approved biologic products, contribute to regulatory planning in emerging markets
Seniority
Senior, hands-on IC with strategic oversight
