Position Description
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.
The Senior Director serves as a key regulatory partner to Technical Operations, Quality, and Supply Chain, and acts as the primary CMC regulatory interface with global health authorities for post-approval activities, including supplements, variations, annual reports, and inspection support.
Specific Job Duties
- 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
Required Education, Experience, or Qualifications
- Bachelor's or Master's degree in life sciences (biochemistry, chemistry, biology, biochemical engineering, or related field); PhD preferred
- Minimum of 15 years of biopharmaceutical industry experience, with significant experience in post-approval CMC regulatory affairs for cell and gene therapies
- Demonstrated experience leading post-approval submissions, including supplements, variations, and annual reports, and supporting health authority GMP inspections
- 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