Associate Director, Global Regulatory Science, CMC
Core
Develop and implement global CMC regulatory strategies for Moderna's mRNA medicine portfolio to support international regulatory submissions.
Role type
Senior IC Regulatory Affairs Director (CMC)
Builds
Global regulatory submissions for mRNA medicines
Domain
Biopharmaceuticals / mRNA therapeutics
Required skills
Global CMC regulatory strategy, International regulatory submissions, CTD format expertise, EU and ROW regulations, Cgmp compliance, Change control assessment, Cross-functional team leadership
Preferred skills
MS in Pharmaceutics/Chemistry/Chemical Engineering, Experience in vaccines/oncology/rare diseases, Generative AI tools for regulatory processes
Technologies
Generative AI tools
Responsibilities
Develop global CMC regulatory strategies, Lead regulatory CMC activities throughout product development, Prepare and review CMC sections of regulatory submissions, Provide expert CMC regulatory guidance to Manufacturing and Quality teams, Lead CMC regulatory discussions with global health authorities, Oversee multiple global development programs and evaluate CMC change controls
Seniority
Senior, hands-on IC