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Regulatory Project Manager, New Registration CMC, CMC Excellence
Within the CMC RA group, the New Registration CMC team bring together the operational and execution aspects for key regulatory deliverables such as new marketing applications, product expansion dossiers and CTA submissions. The New Registration CMC team provides regulatory support across small molecules, biopharm and vaccines products.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Independently assesses, manages, and/or drives the CMC submission deliverables, coordinates, timely prepares and authors multiple complex CMC technical regulatory documents to support applications for clinical trials and marketing authorisation across Rx, Bx and Vx portfolios in accordance with the applicable regulatory and scientific standards, taking into account the evolving regulatory requirements
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