Sr. Director, Regulatory CMC

About the role

The Senior Director, Regulatory CMC is responsible for defining and executing global CMC regulatory strategy for approved and late-stage gene therapy products, with a strong emphasis on lifecycle management, change management, and sustained regulatory compliance. This role provides strategic regulatory leadership across Genetix programs, ensuring efficient implementation of post-approval manufacturing, analytical, and control changes while maintaining product supply and inspection readiness.

Responsibilities

• Provide strategic leadership for post-approval CMC lifecycle management activities for Genetix gene therapy products, including planning and execution of global supplements, variations, and annual regulatory filings
• Own and drive global CMC change management strategy, assessing manufacturing, analytical, raw material, facility, and control strategy changes and defining optimal and aggressive regulatory pathways for implementation
• Lead regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness, including responses to health authority questions and commitments
• Serve as the primary regulatory CMC lead for post-approval health authority interactions, including Type C/Scientific Advice meetings, responses to information requests, and support of GMP inspections
• Partner closely with Pharmaceutical Sciences, Technical Operations, Quality, Supply Chain, and Program Teams to ensure alignment between regulatory strategy and operational execution
• Provide regulatory oversight and approval of post-approval CMC documentation, ensuring consistency with approved dossiers and global regulatory requirements
• Drive adherence to global CMC regulatory standards and guidance (FDA, EMA, ICH) applicable to commercial and post-approval gene therapy products
• Contribute to and lead regulatory intelligence efforts related to post-approval expectations, emerging guidance, and evolving inspection trends impacting gene therapy products
• Mentor and develop Regulatory CMC team members, building scalable post-approval regulatory capabilities to support Genetix portfolio growth
• Represent Regulatory CMC on cross-functional governance forums, providing clear, risk-based regulatory recommendations

Qualifications

• Minimum of 15 years of biopharmaceutical industry experience, with significant experience in post-approval CMC regulatory affairs for cell and gene therapies
• Strong working knowledge of commercial manufacturing and lifecycle management for complex biologics and gene therapy products
• Excellent written and verbal communication skills with proven ability to translate complex technical issues into clear regulatory strategies
• Proven leadership skills, including strategic thinking, people development, cross-functional influence, and decision-making in a matrix environment
• Deep understanding of GMP, CMC regulatory requirements, and global regulatory frameworks (FDA, EMA, ICH)
• Highly organized, detail-oriented, and solution-focused, with the ability to manage multiple priorities and drive execution to completion

Benefits

Genetix offers a comprehensive and competitive benefits suite to support a variety of employee needs, including comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.

Pay

$156,000 - $316,500 USD

Equal Opportunity Employer

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.