Director, Global Regulatory Affairs
Stoke Therapeutics
June 24, 2026
Remote friendly (Bedford, MA)
United States
Corporate Functions
Position Purpose:
The Director, Global Regulatory Strategy will develop and deliver global regulatory strategies to ensure products are developed, approved, and maintained in compliance with health authority requirements and aligned with corporate strategy for Stoke’s portfolio. Provides regulatory leadership for activities related to development of Stoke programs and reports to the Executive Director, Global Regulatory Strategy.
Key Responsibilities:
- Define and drive regulatory strategy for assigned activities/programs.
- Represent Regulatory Affairs in internal teams to align regulatory plans with business objectives and development timelines.
- Anticipate regulatory risks and develop mitigation strategies; educate internal stakeholders on risk and risk/benefit options.
- Serve as primary contact for assigned projects with the FDA and other regulatory agencies as needed.
- Plan and execute regulatory agency meetings and interactions per regulatory strategy.
- Oversee preparation and submission of global regulatory submissions to support program development, registration, and maintenance activities.
- Contribute to continuous improvement of processes and strategies; recommend enhancements in area of expertise.
- Identify and monitor regulatory and policy issues.
- Develop and maintain regulatory knowledge; guide regulatory staff and management; identify need for new/expanded policies, processes, and SOPs.
Required Skills & Experience:
- 8+ years Regulatory Affairs experience in the pharmaceutical industry.
- S., M.S., or Ph.D. in a scientific discipline (preferred).
- Experience in rare disease drug development (preferred); neurology indications ideal.
- Experience preparing major regulatory submissions and amendments/supplements; direct experience interfacing with regulatory authorities.
- Excellent verbal, written, negotiation, and interpersonal skills.
- Strong analytical and problem-solving skills; adaptable to changing priorities/deadlines.
- Proven ability to manage senior personnel across medical, scientific, and manufacturing teams.
- Organized, self-motivated; works well under pressure; detail oriented with effective communication.
Compensation & Benefits:
- Anticipated salary range: $248,000–$280,000; annual bonus and equity participation.
- Benefits include medical/dental/vision; life and long-/short-term disability; paid parental leave; 401(k) with match; unlimited vacation; tuition assistance; ESPP.
Travel:
- Approximately 10% travel.
Application Instructions:
- Apply at https://www.stoketherapeutics.com/careers/
The Director, Global Regulatory Strategy will develop and deliver global regulatory strategies to ensure products are developed, approved, and maintained in compliance with health authority requirements and aligned with corporate strategy for Stoke’s portfolio. Provides regulatory leadership for activities related to development of Stoke programs and reports to the Executive Director, Global Regulatory Strategy.
Key Responsibilities:
- Define and drive regulatory strategy for assigned activities/programs.
- Represent Regulatory Affairs in internal teams to align regulatory plans with business objectives and development timelines.
- Anticipate regulatory risks and develop mitigation strategies; educate internal stakeholders on risk and risk/benefit options.
- Serve as primary contact for assigned projects with the FDA and other regulatory agencies as needed.
- Plan and execute regulatory agency meetings and interactions per regulatory strategy.
- Oversee preparation and submission of global regulatory submissions to support program development, registration, and maintenance activities.
- Contribute to continuous improvement of processes and strategies; recommend enhancements in area of expertise.
- Identify and monitor regulatory and policy issues.
- Develop and maintain regulatory knowledge; guide regulatory staff and management; identify need for new/expanded policies, processes, and SOPs.
Required Skills & Experience:
- 8+ years Regulatory Affairs experience in the pharmaceutical industry.
- S., M.S., or Ph.D. in a scientific discipline (preferred).
- Experience in rare disease drug development (preferred); neurology indications ideal.
- Experience preparing major regulatory submissions and amendments/supplements; direct experience interfacing with regulatory authorities.
- Excellent verbal, written, negotiation, and interpersonal skills.
- Strong analytical and problem-solving skills; adaptable to changing priorities/deadlines.
- Proven ability to manage senior personnel across medical, scientific, and manufacturing teams.
- Organized, self-motivated; works well under pressure; detail oriented with effective communication.
Compensation & Benefits:
- Anticipated salary range: $248,000–$280,000; annual bonus and equity participation.
- Benefits include medical/dental/vision; life and long-/short-term disability; paid parental leave; 401(k) with match; unlimited vacation; tuition assistance; ESPP.
Travel:
- Approximately 10% travel.
Application Instructions:
- Apply at https://www.stoketherapeutics.com/careers/