Director, Regulatory Affairs - CMC

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 ~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.

The Director, Regulatory CMC is responsible for contributing to the development of Stoke’s products by proposing and implementing global CMC regulatory strategies, leading cross-functional CMC submissions and providing regulatory guidance to cross-functional teams and functional areas for assigned programs from the pre-clinical stage through approval and life-cycle management. This position reports to the Sr. Director of Regulatory CMC.

• Responsible for developing Regulatory CMC submission strategies and leading cross-functional teams to action on those strategies to meet program and company goals.
• Lead multidisciplinary teams to prepare high-quality, accurate and compliant CMC sections of regulatory submissions, as well as responses to Regulatory Agency questions
• Plan, manage, author, review, and obtain stakeholder alignment to facilitate the submission of to support initial INDs/CTAs, marketing applications, supplements and variations
• Assess and communicate regulatory requirements to ensure all CMC activities comply with applicable regulations and guidelines
• Proactively and effectively communicate risks and potential mitigations to teams and key stakeholders
• Provide regulatory support for relevant quality systems such as change control, deviations, and inspection management
• Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation
• Manage and ensure compliance with all reporting requirements, including annual and periodic reports
• Effectively plan, organize and contribute to formal meetings with global regulatory agencies to ensure alignment on CMC strategies, resolve CMC issues and oversee proactive interactions for initial INDs/CTAs, marketing registration applications, supplements and variations
• Develop, review, and maintain Regulatory CMC departmental policies and SOPs
• Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines, and other international regulatory regulations and guidelines, as needed to support global clinical and commercial programs
• Additional duties as assigned

• Advanced degree in Chemistry or related science (e.g., M.S., Ph.D.)
• Minimum of 10 years of experience in the biopharmaceutical or pharmaceutical industry
• Direct experience of the CMC components of IMPD and CTD (IND, NDA, MAA) submissions
• Basic understanding of oligonucleotide drug development is desirable
• Experience in managing CMC change control
• Knowledge and understanding of relevant regulatory…