Senior Manager, Regulatory Affairs, CMC

Stoke Therapeutics•Bedford, MA

3d•$181,000 - $213,000•Hybrid

About The Position

The Regulatory CMC Senior 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. It is hybrid or remote, currently based in Bedford, Massachusetts, and later based in Waltham, Massachusetts, as Stoke plans to move there by the end of 2026. The role requires approximately 0% travel; remote employees should expect periodic travel to Bedford or Waltham. Stoke Therapeutics is a biotechnology company developing RNA medicines using its proprietary TANGO approach to restore naturally occurring protein levels. Its first medicine in development, zorevunersen, is being evaluated in a Phase 3 study for Dravet syndrome. Stoke is headquartered in Bedford, Massachusetts.

Requirements

Bachelor’s degree in a scientific, pharmaceutical, or engineering discipline; an advanced degree is preferred.
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 the United States and European Union.
Direct experience with commercial-phase programs, post-approval CMC requirements, and 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 areas: 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

Combination product and/or device experience.
Regulatory experience beyond the United States and European Union.
Experience working in complex, matrixed environments.
Oligonucleotide drug development experience.
Advanced degree.

Responsibilities

Prepare and execute global CMC regulatory 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, collaborate with subject matter experts, and manage document review and approval workflows.
Analyze and interpret technical information to assess its impact on regulatory strategy and decisions.
Assess change controls for regulatory impact and manage the implementation system 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 to improve regulatory operational alignment and efficiency.
Build and maintain relationships within the Regulatory Affairs department and Technical Operations (CMC) teams.