Global Regulatory CMC Lead for Biologics

Il y a 2 jours

Saclay, Île-de-France Excelya Temps plein 90 000 € - 140 000 €/an

Excelya is seeking a Senior Regulatory Consultant to deliver strategic and operational Regulatory CMC leadership for a global Antibody-Drug Conjugate (ADC) biologics program. The role requires steering global CMC activities for MAA/BLA submissions, with an emphasis on strategy and matrix-management leadership.

The consultant will interact with global health authorities (FDA, EMA) and guide cross-functional teams to ensure regulatory readiness and lifecycle management of biologics products.