About Genetix Biotherapeutics At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values: Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints.

This is personal and we approach every challenge with radical care. The Director, Regulatory CMC is responsible for leading execution of global CMC regulatory strategies for approved and late-stage gene therapy products, with a primary focus on lifecycle management, change management, and regulatory compliance. This role supports the development and delivery of post-approval regulatory strategies and ensures effective implementation of manufacturing, analytical, and control changes across global markets.

Requirements

and operational execution. This individual contributes to regulatory interactions with health authorities and plays a key role in supporting post-approval submissions, inspection readiness, and ongoing compliance activities. This is a full-time hybrid position (3 days a week) in our Somerville, Massachusetts office.

Ensure adherence to global CMC regulatory standards and guidance (FDA, EMA, ICH) applicable to commercial and post-approval gene therapy products Monitor and apply regulatory intelligence related to post-approval expectations, emerging guidance, and inspection trends Provide mentorship and guidance to junior Regulatory CMC team members as appropriate Represent Regulatory CMC on cross-functional teams and provide clear, risk-based regulatory input to support decision-making Required Education, Experience, or

, and global regulatory frameworks (FDA, EMA, ICH) Strong written and verbal communication skills, with the ability to translate technical information into clear regulatory documentation Demonstrated ability to work effectively in cross-functional, matrixed environments Strong organizational skills and ability to manage multiple priorities in

Qualifications

Bachelor’s or Master’s degree in life sciences (biochemistry, chemistry, biology, biochemical engineering, or related field) Minimum of 10–12 years of biopharmaceutical industry experience, with relevant experience in CMC regulatory affairs for biologics or gene therapy products Experience supporting post-approval CMC submissions (e.g., supplements, variations, annual reports) and regulatory interactions Strong understanding of commercial manufacturing and lifecycle management for complex biologics and/or gene therapy products Solid knowledge of GMP, CMC regulatory