Director, Global Regulatory CMC - Gene Therapy

Initial Therapeutics, Inc.; Boston (MA); On-site; USD 163,500 - 281,600; Full time

Benefits offered by this job

401(k) plan

Pension

Medical/dental/vision benefits

Life insurance

Job summary

Lilly is seeking an experienced Regulatory CMC leader to develop and implement global CMC strategies for gene therapy programs. You will lead the preparation of CMC sections for IND/CTA, BLA/MAA submissions and serve as the primary liaison with major health authorities.

The role requires 5+ years in regulatory CMC for ATMPs, strong leadership, and collaboration with R&D, Manufacturing, Quality, and Clinical teams. Excellent communication skills and deep knowledge of ICH guidelines are essential.

Qualifications

• Bachelor’s degree in a scientific field required; advanced degree preferred.
• 5+ years in regulatory CMC for gene therapy/ATMPs.
• 5+ years of experience with IND/CTA, BLA/MAA and health authority interactions.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Develop and implement global regulatory CMC strategies for gene therapy programs.
• Lead preparation and review of CMC sections for regulatory submissions.
• Act as primary regulatory CMC liaison with health authorities (FDA, EMA, PMDA).
• Provide CMC guidance to cross-functional development teams.
• Identify regulatory CMC risks and develop mitigation strategies.

Skills

Regulatory CMC expertise

Gene therapy knowledge

Leadership

Cross-functional collaboration

Education

Bachelor's degree in science

MS or PhD preferred

Tools

Regulatory information management

Microsoft Office

Job description

Lilly is seeking an experienced Regulatory CMC leader to develop and implement global CMC strategies for gene therapy programs. You will lead the preparation of CMC sections for IND/CTA, BLA/MAA submissions and serve as the primary liaison with major health authorities.

The role requires 5+ years in regulatory CMC for ATMPs, strong leadership, and collaboration with R&D, Manufacturing, Quality, and Clinical teams. Excellent communication skills and deep knowledge of ICH guidelines are essential.