Director, Regulatory CMC

Genetix Biotherapeutics•Somerville, MA

7d•$220,000 - $235,000•Hybrid

About The Position

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.

Requirements

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

Responsibilities

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