Position Purpose:The Regulatory CMC Senior Manager is responsible for contributing 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 for multiple programs. This position will report to the Director of Regulatory CMC.
Key Responsibilities:- Prepares and executes global regulatory CMC strategy for development programs and future commercial programs, including new applications, information amendments, annual reports, supplements/ variations, and responses to health authority questions.
- Lead author, and able to collaborate with Subject Matter Experts, for Quality Modules. Effectively manage document review and approval workflows.
- Analyzes and interprets technical information for impact to regulatory strategy and decisions
- Assesses change controls for regulatory impact and manages the implementation system for regulatory compliance
- Develops process(es) to track regulatory dossier lifecycle management, health authority questions, and post approval commitments, as needed
- Develops and implements documents, policies, and/or procedures for regulatory operational alignment and efficiencies
- Builds and maintains relationships within the Regulatory Affairs department and Technical Operations (CMC) teams
Required Skills & Experience: - BS/ BA degree in scientific, pharmaceutical or engineering discipline; advanced degree preferred
- Minimum of 8 years of industry experience, including a minimum of 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 and implementation of regulatory milestones (e.g., Annual Reports)
- Deep understanding of Module 3 sections and associated ICH, FDA, EMA regulations and guidance documents
- Experience authoring Quality Modules 2.3 and 3; and health authority engagement content (e.g., FDA Briefing Books)
- Practical experience in one of the following areas: manufacturing; process development; validation; analytical development, and/or quality.
- Understanding of technical operations functions and systems including, but not limited to, technical risk assessments, change controls
- Strong oral and written communication skills
- Direct experience with Veeva RIM required
- Preferred Experience:
- Combination Product and/or device experience
- Global (beyond US, EU) regulatory experience
- Working in complex and matrix environments
- Oligonucleotide drug development
Location(s): Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is a hybrid position, or remote, currently based in Bedford and will later be based in Waltham.
Travel:This position will require approximately [0%] travel, unless remote then periodic travel to Bedford/ Waltham is expected.
Compensation & Benefits:At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.
The anticipated salary range for this role is
$181,000 - $213,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.
Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).
