Associate Director, Global Regulatory Strategy

Associate Director, Global Regulatory Strategy 1 day ago Be among the first 25 applicants 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 approach, the company 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 entered into a strategic collaboration with Biogen in 2025 to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights. STK-002 is Stoke’s proprietary antisense oligonucleotide (ASO) in clinical development for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. STK-002 has been granted orphan drug designation by the FDA. A Phase 1 study (OSPREY) of STK-002 in people with ADOA is now underway. The company is also conducting early research in Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals. Stoke’s initial focus is on diseases of the central nervous system and the eye that are caused by a loss of approximately 50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for the Company’s proprietary approach. Position Purpose: The Associate Director of Regulatory Strategy supports the development and implementation of innovative global regulatory strategies for preclinical and early clinical development products, as assigned. This role will be responsible for collaborating across teams to provide regulatory guidance and manage regulatory submissions to meet corporate goals. Serves as a liaison between internal teams and external partners to communicate regulatory plans and updates, navigate complex regulatory issues and ensure alignment across program teams/subteams. This position reports to the Executive Director, Regulatory Affairs. Key Responsibilities: Support the development and implementation of global regulatory strategies for assigned programs, ensuring alignment with corporate objectives and regulatory requirements. Lead or support the development of high-quality regulatory documents, including authoring and/or reviewing documents for IND/CTA submissions, health authority meetings, regulatory applications (orphan, BTD, etc) and responses to health authority requests for information. Contribute to the planning and execution of successful regulatory agency meetings and interactions; may independently lead regulatory communication and interactions with the health authority. Represent Regulatory on clinical study teams, cross-functional development subteams, and program teams as assigned to provide strategic regulatory guidance and support to achieve product development goals. Contribute to the development of risk assessments pertaining to the execution, quality, safety, and efficacy aspects of programs and applications. Collaborate with internal and external stakeholders, manage and oversee third‑party vendors and consultants to ensure high-quality submissions and successful execution of clinical trials and regulatory strategies. Monitors the development of new regulatory requirements or guidance documents and advises product teams of the impact on the business or development programs. Lead or contribute to process improvement or operational excellence initiatives within Regulatory function or Stoke in general, as applicable. Stay current with evolving regulatory requirements and best practices, and ensure compliance with all applicable regulations, guidelines, and industry standards. Required Skills & Experience: Bachelor’s degree in health sciences or related field; an advanced degree is preferred. Minimum of 6 years of relevant pharmaceutical or biotech industry experience within regulatory affairs. Prior experience in regulatory strategy supporting global clinical trials. Experience in rare disease drug development is highly desirable. Ability to assess and understand complex scientific information, regulatory precedents, competitive intelligence, and regulatory guidelines and make recommendations based on assessment. Excellent verbal, written, negotiation, and interpersonal skills. Analytical thinker with excellent problem‑solving skills and the ability to adapt to changing priorities and deadlines. Proven ability to carry out complex projects, with flexibility and adaptability. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. Location(s): Stoke is located in Bedford, MA. This position is a hybrid position with an office setting based in Bedford, MA location. Travel: This position will require approximately 10% travel. Compensation & Benefits: 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 $189,000 - $227,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation. Our benefits package includes medical, dental and vision insurance; life, long‑and short‑term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in we Employee Stock Purchase Program (ESPP). Culture & Values: At Stoke, we believe that innovation, the ability to successfully advance our ground‑breaking 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’s 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. Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center. https://www.stoketherapeutics.com/careers/ For more information, visit https://www.stoketherapeutics.com/. 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