Senior Manager, Regulatory Affairs, CMC

Role: Senior Manager of Regulatory CMC at Stoke Therapeutics, focusing on developing and executing global regulatory strategies for RNA-based therapeutics, including antisense oligonucleotides for CNS and eye diseases. Responsibilities: lead CMC lifecycle management, author technical Quality Modules, interpret technical data for regulatory impact, manage change controls, and develop operational processes for regulatory compliance. Requirements: BS/BA in scientific, pharmaceutical, or engineering fields; 8+ years industry experience with at least 5 years in CMC Regulatory Affairs; proven success in US and EU regulatory strategies; experience with post-approval CMC requirements, Veeva RIM, and technical areas such as manufacturing, process development, validation, or analytical development. Preferred: experience with oligonucleotides, complex matrix environments, and global (beyond US/EU) regulatory experience. HighValue: biotech (RNA modalities), late-stage development (Phase 3), post-approval lifecycle, US/EU markets, regulatory submissions, and technical operations. Work setup: hybrid or remote in Bedford/Waltham, MA; minimal travel required.