Director, Regulatory Affairs - CMC

Stoke Therapeutics • Bedford, MA

3h • Hybrid

About The Position

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.

Requirements

• 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.

Responsibilities

• 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

Benefits

• 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
• participation in our Employee Stock Purchase Program (ESPP)

What This Job Offers

• Job Type: Full-time
• Career Level: Director