Director, Global Regulatory Affairs

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 on diseases of the central nervous system and the eye that are 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. Position Purpose 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. Key Responsibilities 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 on 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 their 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. Required Skills & Experience 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 and neurology indications ideal. Experience in the preparation of major regulatory submissions and supportive amendments or supplements for programs, including both early phase and late phase aspects of the project; direct experience in 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 effectively manage a variety of senior personnel including medical, scientific, and manufacturing staff. Well organized, self‑motivated hard worker, smart independent thinker, demonstrated ability to work well under pressure and deadlines, detail oriented, with effective written and oral communication skills. Location(s) 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 position, currently based in Bedford and will later be based in Waltham. Travel This position will require approximately 10% travel. Compensation & Benefits The anticipated salary range for this role is $248,000 - $280,000. In addition to base salary, Stoke offers an annual bonus and equity participation. Benefits include medical, dental, and vision insurance; life, long‑ and short‑term disability insurance; paid parental leave; a 401(k) plan with company match; unlimited vacation time; tuition assistance; and participation in our Employee Stock Purchase Program (ESPP). Culture & Values At Stoke, we believe that innovation, advancing our groundbreaking science, and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation. Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee‑led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do. Equal Employment Opportunity All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status. Stoke participates in E‑Verify. #J-18808-Ljbffr