Senior Regulatory CMC Manager (Hybrid/Remote)

Stoke Therapeutics; Bedford (MA); Hybrid; USD 181,000 - 213,000; Full time

Benefits offered by this job

Annual bonus

Equity participation

Medical, dental and vision insurance

401K with company match

Unlimited vacation

Tuition assistance

ESPP

Job summary

Stoke Therapeutics is seeking a Regulatory CMC Senior Manager to contribute to global regulatory strategies, lifecycle management, and cross-functional guidance across programs. Reports to the Director of Regulatory CMC.

The role focuses on leading CMC regulatory strategies for development and potential commercialization, with emphasis on Module 3, health authority engagement, and global submissions. Location is hybrid/remote in Bedford, MA, with a move to Waltham; travel minimal; salary range

Qualifications

• 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 regulatory experience; Working in complex and matrix environments; Oligonucleotide drug development

Responsibilities

• Prepares and executes global regulatory CMC strategy for development programs, including new applications, amendments, annual reports, supplements and responses to health authority questions
• Lead author, and collaborate with SMEs, for Quality Modules; 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 processes to track regulatory dossier lifecycle management, health authority questions, and post-approval commitments
• Develops and implements documents, policies, and procedures for regulatory operational alignment and efficiencies
• Builds and maintains relationships within Regulatory Affairs and Technical Operations (CMC) teams
• Location: Stoke is in Bedford, MA; hybrid/remote; moving to Waltham; travel minimal

Skills

Regulatory strategy development

CMC regulatory affairs

US & EU regulatory experience

Health authority engagement

Veeva RIM

Quality Modules

Regulatory lifecycle management

Technical writing

Cross-functional collaboration

Communication skills

Education

BS/BA in science/engineering

Advanced degree preferred

Tools

Veeva RIM

MS Office

Job description

Stoke Therapeutics is seeking a Regulatory CMC Senior Manager to contribute to global regulatory strategies, lifecycle management, and cross-functional guidance across programs. Reports to the Director of Regulatory CMC.

The role focuses on leading CMC regulatory strategies for development and potential commercialization, with emphasis on Module 3, health authority engagement, and global submissions. Location is hybrid/remote in Bedford, MA, with a move to Waltham; travel minimal; salary range