CMC Regulatory Lead – Biologics

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8d0oio

Parexel is seeking a Senior Regulatory Affairs Associate to drive post-approval CMC activities for biologics and vaccines. You will collaborate with manufacturing, QA, QC and regulatory teams to shape submission strategies and support variations, renewals and market expansions, with remote options across Europe.
Responsibilities include developing post-approval CMC submissions, assessing regulatory impact of changes, coordinating with cross-functional teams, reviewing study reports, and writing/

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8d0oio