Senior Regulatory Affairs, CMC Biologics/Vaccines
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Parexel is seeking a Senior Regulatory Affairs Associate to drive post-approval regulatory activities focused on CMC for biological and vaccine products. You will collaborate across manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance.
Responsibilities include developing post-approval CMC submission strategies for variations, renewals, market expansions, and annual reports; coordinating submission preparation with manufacturing, supply chain,