Manager, Regulatory Clinical Trial Authorization (CTA)

Overview

The Manager, Clinical Trial Authorization (CTA) is responsible for ensuring that CTA activities for assigned clinical studies are planned, governed, and overseen in line with CSL regulatory expectations, quality standards, and development timelines. Reporting to the Director, Global Regulatory CTA, the role translates global CTA direction into clear, study‑specific regulatory approaches, provides guidance to Study Teams and partners, and acts as the first line CTA point of contact across functions. The position ensures that CTA activities delivered by external partners are appropriately overseen, risks are identified early and managed proactively. The role maintains a strong focus on quality, inspection readiness, and continuous improvement by monitoring performance, contributing to metrics and dashboards, driving pragmatic process enhancements, and representing CTA internally during audits and inspections, as required. This role reports to the Director, Global...