Director, Global Regulatory Affairs
Stoke Therapeutics
August 18, 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 in alignment with corporate strategy for Stoke’s portfolio.
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 regulatory risk-benefit and mitigation options.
- Serve as primary contact for assigned projects with the FDA and other regulatory agencies.
- 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.
- Contribute to continuous improvement of processes and strategies; recommend improvements in area of expertise.
- Identify and monitor regulatory and policy issues.
- Develop and maintain regulatory knowledge; provide guidance to regulatory staff and management; identify and implement new/expanded regulatory policies, processes, and SOPs.
Required/Preferred Qualifications:
- 8+ years minimum Regulatory Affairs experience in the pharmaceutical industry.
- S., M.S., or Ph.D. in a scientific discipline (preferred).
- Rare disease drug development experience (preferred); neurology indications ideal.
- Experience preparing major regulatory submissions and amendments/supplements across early and late phases; direct interfacing with regulatory authorities.
Required Skills:
- Excellent verbal, written, negotiation, and interpersonal skills.
- Analytical, strong problem-solving; adapt to changing priorities/deadlines.
- Proven ability to manage senior personnel across medical, scientific, and manufacturing.
- Well organized, self-motivated; detail oriented; effective written and oral communication.
Travel:
- ~10% travel.
Compensation & Benefits:
- Anticipated salary range: $248,000–$280,000; plus annual bonus and equity.
- Medical/dental/vision; life and short-/long-term disability; paid parental leave; 401(k) with match; unlimited vacation; tuition assistance; ESPP.
Application:
- Apply via 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 in alignment with corporate strategy for Stoke’s portfolio.
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 regulatory risk-benefit and mitigation options.
- Serve as primary contact for assigned projects with the FDA and other regulatory agencies.
- 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.
- Contribute to continuous improvement of processes and strategies; recommend improvements in area of expertise.
- Identify and monitor regulatory and policy issues.
- Develop and maintain regulatory knowledge; provide guidance to regulatory staff and management; identify and implement new/expanded regulatory policies, processes, and SOPs.
Required/Preferred Qualifications:
- 8+ years minimum Regulatory Affairs experience in the pharmaceutical industry.
- S., M.S., or Ph.D. in a scientific discipline (preferred).
- Rare disease drug development experience (preferred); neurology indications ideal.
- Experience preparing major regulatory submissions and amendments/supplements across early and late phases; direct interfacing with regulatory authorities.
Required Skills:
- Excellent verbal, written, negotiation, and interpersonal skills.
- Analytical, strong problem-solving; adapt to changing priorities/deadlines.
- Proven ability to manage senior personnel across medical, scientific, and manufacturing.
- Well organized, self-motivated; detail oriented; effective written and oral communication.
Travel:
- ~10% travel.
Compensation & Benefits:
- Anticipated salary range: $248,000–$280,000; plus annual bonus and equity.
- Medical/dental/vision; life and short-/long-term disability; paid parental leave; 401(k) with match; unlimited vacation; tuition assistance; ESPP.
Application:
- Apply via https://www.stoketherapeutics.com/careers/