Director, Global Regulatory Affairs

About Stoke

Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally‑occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study.

Stoke’s initial focus is diseases of the central nervous system and the eye caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit

The Director, Global Regulatory Strategy will be responsible for developing and delivering global regulatory strategies to ensure products are developed, approved, and maintained in compliance with health authority requirements and in alignment with the corporate strategy for Stoke’s portfolio. This role will provide regulatory leadership for various activities related to the development of Stoke programs and report to the Executive Director, Global Regulatory Strategy.

• Define and drive regulatory strategy for assigned activities/programs.
• Represent RA in various internal teams to align regulatory plans with business objectives and development timelines.
• Anticipate regulatory risks and design mitigation strategies. Develop and present information to educate internal stakeholders about risk (e.g., corporate evaluations of regulatory risk‑benefit, options for risk mitigation).
• Serve as primary contact for assigned projects with the FDA and other regulatory agencies as needed.
• Plan and execute successful 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 the continuous improvement of existing processes and strategies, providing recommendations in the area of expertise.
• Identify and monitor regulatory and policy issues.
• Develop and maintain current regulatory knowledge and provide guidance to regulatory staff and company management; identify the need for new or expanded regulatory policies, processes and SOPs, and approve and ensure implementation to establish a compliant culture.

• 8+ years minimum of 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 in preparing major regulatory submissions and supportive amendments or supplements for programs, including both early‑phase and late‑phase aspects of the project; direct experience interfacing with relevant regulatory authorities.
• Excellent verbal, written, negotiation, and interpersonal skills.
• Analytical thinker with excellent problem‑solving skills and the ability to adapt to changing priorities and deadlines.
• Strong interpersonal skills and proven ability to manage a variety of senior personnel including medical, scientific, and manufacturing staff.
• Well organized, self‑motivated, hard‑working, smart independent thinker with demonstrated ability to work well under pressure and deadlines, detail oriented, and with effective written and oral communication skills.

Stoke is located in Bedford, MA, and will move to a new location in Waltham, MA by the end of 2026. This position is a hybrid, currently based in Bedford and later in Waltham.

This position will require approximately 10% travel.

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 $248,000 - $280,000, with final offers determined by role…