Cmc Regulatory Lead – Biologics & Vaccines (Remote)

10 ott - Bardi
Parexel

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.
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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 a distanza/a casa.

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