Director, Global Regulatory CMC - Gene Therapy

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.