Senior Regulatory Affairs

11 ott - Montà
Parexel

Parexel in Italy (Catania area) is seeking a Senior Regulatory Affairs Associate to drive post-approval regulatory activities focused on CMC for biologics and vaccines. 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, assessing regulatory impact of quality changes, coordinating submissions, and writing or reviewing content for health
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