Director, Regulatory Affairs - CMC

Position Purpose:

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.

Key Responsibilities:

Specific key responsibilities include, but are not limited to:

• 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

Required Skills & Experience:

• 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 and compliance guidelines including those in the US, EU, UK and Canada as well as the ICH guidelines
• Excellent written and verbal communication skills and attention to detail
• Demonstrated strong organizational skills including the ability to prioritize tasks and to adhere to timelines.

Location(s):

Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is a hybrid position with an office setting based in our 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 $ 233,000 – $260,000. 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 our Employee Stock Purchase Program (ESPP).