Director, Global Regulatory Affairs
Stoke Therapeutics
10 days ago
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 Stoke’s corporate strategy. Provides regulatory leadership for development activities 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/design mitigation strategies; educate internal stakeholders on risk and options.
- Serve as primary contact for assigned projects with the FDA and other regulatory agencies.
- Plan and execute successful regulatory agency meetings and interactions.
- Oversee preparation and submission of global regulatory submissions (development, registration, and maintenance).
- Recommend improvements to processes and strategies.
- Identify and monitor regulatory and policy issues.
- Develop and maintain regulatory knowledge; guide regulatory staff and management; identify and implement 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 preparing major regulatory submissions and amendments/supplements; interfacing with regulatory authorities.
- Excellent verbal, written, negotiation, and interpersonal skills.
- Analytical/problem-solving skills; adapt to changing priorities and deadlines.
- Ability to manage senior cross-functional personnel effectively.
Preferred:
- Rare disease drug development; neurology indications.
Compensation & Benefits (if included):
- Anticipated salary range: $248,000–$280,000; annual bonus and equity participation.
- Medical/dental/vision; life/long- and short-term disability; paid parental leave; 401K match; unlimited vacation; tuition assistance; ESPP.
Application Instructions:
Apply via Stoke’s Career Center: 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 Stoke’s corporate strategy. Provides regulatory leadership for development activities 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/design mitigation strategies; educate internal stakeholders on risk and options.
- Serve as primary contact for assigned projects with the FDA and other regulatory agencies.
- Plan and execute successful regulatory agency meetings and interactions.
- Oversee preparation and submission of global regulatory submissions (development, registration, and maintenance).
- Recommend improvements to processes and strategies.
- Identify and monitor regulatory and policy issues.
- Develop and maintain regulatory knowledge; guide regulatory staff and management; identify and implement 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 preparing major regulatory submissions and amendments/supplements; interfacing with regulatory authorities.
- Excellent verbal, written, negotiation, and interpersonal skills.
- Analytical/problem-solving skills; adapt to changing priorities and deadlines.
- Ability to manage senior cross-functional personnel effectively.
Preferred:
- Rare disease drug development; neurology indications.
Compensation & Benefits (if included):
- Anticipated salary range: $248,000–$280,000; annual bonus and equity participation.
- Medical/dental/vision; life/long- and short-term disability; paid parental leave; 401K match; unlimited vacation; tuition assistance; ESPP.
Application Instructions:
Apply via Stoke’s Career Center: https://www.stoketherapeutics.com/careers/