Senior Manager, Regulatory Affairs, CMC
Stoke Therapeutics · Bedford, MA
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Role summary
Stoke Therapeutics seeks a Senior Manager of Regulatory Affairs for Chemistry, Manufacturing, and Controls (CMC) to develop global regulatory strategies, manage lifecycle initiatives, and guide cross-functional teams across multiple antisense oligonucleotide programs in development and commercial phases.
What they're looking for
- BS/BA in scientific, pharmaceutical, or engineering discipline; advanced degree preferred
- Minimum 8 years industry experience, including 5+ years in CMC regulatory affairs
- Experience developing regulatory strategies for US and EU markets
- Commercial-phase program experience with post-approval CMC requirements
- Deep knowledge of ICH, FDA, and EMA regulations and Module 3 guidance
- Proven authorship of Quality Modules 2.3, 3, and health authority engagement materials
- Background in manufacturing, process development, validation, analytics, or quality
What you'll be doing
- Develop and execute global CMC regulatory strategies for development and commercial programs
- Lead authorship of Quality Modules and manage document review workflows with subject matter experts
- Assess regulatory impact of change controls and compliance implementation
- Track regulatory dossier lifecycle, health authority questions, and post-approval commitments
- Build cross-functional relationships with regulatory and technical operations teams
Privacy & handoff
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