Global Regulatory CMC Lead for Biologics & ADC Programs

Excelya Group is seeking a senior regulatory consultant to provide strategic and operational Regulatory CMC leadership for a global Antibody-Drug Conjugate (ADC) biologics program. You will drive regulatory strategy, lead Module 3 CMC content, and coordinate with global health authorities to support MAAs, BLAs, and lifecycle management.

The role requires expertise in ICH, FDA, EMA regulations, and a proven ability to operate in a global matrix with cross-functional teams across development and