Regulatory Affairs Manager CMC

Patients depend on a continuous, compliant supply of medicines reaching the markets that need them. This role sits at the point where science, manufacturing, and regulation meet — translating CMC data into the submissions, change controls, and regulatory strategy that keep that supply moving without interruption.

As a Regulatory Affairs Manager CMC you will drive regulatory CMC strategy for your assigned products, spanning both development and commercial stages, working closely with colleagues across Global Regulatory Affairs CMC, R&D, Quality, and Global Operations. That collaboration shapes the high-quality, compliant CMC regulatory submissions you'll manage end-to-end— new marketing applications, clinical trial applications, variations, supplements, periodic compliance reports, and renewals — each one needing to be technically sound and built to withstand regulatory scrutiny.

You'll also own the regulatory assessment of change controls within CSL's quality m...