Director, Regulatory CMC

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.

The Director partners closely with Technical Operations, Quality, and Supply Chain to ensure alignment between regulatory 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. 

Specific Job Duties

• Lead execution of post-approval CMC lifecycle management activities, including preparation and submission of global supplements, variations, and annual reports
• Support development and implementation of CMC change management strategies, assessing manufacturing, analytical, raw material, facility, and control changes and recommending appropriate regulatory pathways
• Manage regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness, including drafting responses to health authority questions and commitments
• Contribute to regulatory interactions with global health authorities (e.g., FDA, EMA), including support for meetings, information requests, and inspection activities
• Partner with Technical Operations, Quality, Supply Chain, and Program Teams to ensure regulatory strategy aligns with operational plans and timelines
• Author and review post-approval CMC documentation, ensuring consistency with approved dossiers and global regulatory requirements
• 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 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 requirements, 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 a fast-paced environment