Regulatory Project Manager, New Registration CMC, CMC Excellence

Job description

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 Understands internal and external Regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support and advice to various projects, and provide guidance to R&D teams, Quality Control, GSC, QA and LOC...