Hiring: Associate Director, Global Regulatory, CMC Company: Moderna Location: Norwood, MA Job Posted Time: 2026-09-10 14:13:48 About the job Experience: •8+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus •5+ years of experience in Biologics focused Regulatory CMC Required Skills: •Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks •Provide guidance for regulatory CMC aspects of product development projects •Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines •Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions •Perform assessment of manufacturing change controls •Support development of regulatory processes and procedures to support CMC components of regulatory submissions •Actively facilitate and support creation and maintenance of CMC submission templates •Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls Qualifications: •BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required Compensation: •$142,500 - $256,500 / year •Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!