Global Regulatory CMC Lead for Biologics

Il y a 6 jours

Saclay, Île-de-France Excelya Group Temps plein

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.

Postulez maintenant, lisez les détails du poste en faisant défiler la page. Vérifiez bien que vous avez les compétences nécessaires avant d'envoyer votre candidature.

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, xuezdbg and a proven ability to operate in a global matrix with cross-functional teams across development and