CMC Regulatory Lead – Biologics

17 ore fa

Roma, Lazio, Italia PAREXEL Tempo pieno

Parexel is seeking a Senior Regulatory Affairs Associate to drive post-approval CMC activities for biologics and vaccines.

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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. xbvzest

Responsibilities include developing post-approval CMC submissions, assessing regulatory impact of changes, coordinating with cross-functional teams, reviewing study reports, and writing/


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Per questa posizione sono disponibili opzioni di lavoro da remoto/a casa.