Manager, Regulatory Affairs, CMC

Stoke Therapeutics•Bedford, MA

7d•$145,000 - $160,000•Hybrid

About The Position

The Regulatory CMC Manager contributes to the development of Stoke’s products by supporting global CMC regulatory strategies, leading lifecycle management initiatives, and providing regulatory guidance to cross-functional teams across multiple programs. The position reports to the Director of Regulatory CMC. The role prepares and executes regulatory CMC strategies for development and future commercial programs, including applications, amendments, annual reports, supplements or variations, and responses to health authority questions. It authors Quality Modules in collaboration with subject matter experts, manages document review and approval workflows, assesses technical information and change controls for regulatory impact, and supports compliant implementation. The manager also develops processes and documents for dossier lifecycle management, health authority questions, post-approval commitments, and regulatory operational alignment and efficiency. The role builds and maintains relationships within Regulatory Affairs and Technical Operations (CMC). The position is hybrid or remote. Stoke is currently located in Bedford, Massachusetts, and expects to move to Waltham, Massachusetts, by the end of 2026. Travel is expected to be approximately 0%; remote employees may periodically travel to Bedford or Waltham.

Requirements

Bachelor’s degree in a scientific, pharmaceutical, or engineering discipline.
At least 8 years of industry experience, including at least 5 years directly in CMC Regulatory Affairs.
Direct experience developing and implementing successful regulatory strategies in both US and EU markets.
Direct experience with commercial-phase programs and post-approval CMC requirements, including implementation of regulatory milestones such as annual reports.
Deep understanding of Module 3 sections and associated ICH, FDA, and EMA regulations and guidance documents.
Experience authoring Quality Modules 2.3 and 3, and health authority engagement content such as FDA briefing books.
Practical experience in at least one of the following: manufacturing, process development, validation, analytical development, or quality.
Understanding of technical operations functions and systems, including technical risk assessments and change controls.
Strong oral and written communication skills.
Direct experience with Veeva RIM.

Nice To Haves

Advanced degree.
Combination product and/or device experience.
Global regulatory experience beyond the US and EU.
Experience working in complex and matrix environments.
Oligonucleotide drug development experience.

Responsibilities

Prepare and execute global regulatory CMC strategies for development and future commercial programs, including new applications, information amendments, annual reports, supplements or variations, and responses to health authority questions.
Lead-author Quality Modules and collaborate with subject matter experts; manage document review and approval workflows.
Analyze and interpret technical information for its impact on regulatory strategy and decisions.
Assess change controls for regulatory impact and manage implementation systems for regulatory compliance.
Develop processes to track regulatory dossier lifecycle management, health authority questions, and post-approval commitments as needed.
Develop and implement documents, policies, and procedures for regulatory operational alignment and efficiencies.
Build and maintain relationships within Regulatory Affairs and Technical Operations (CMC) teams.