GRA CMC Specialist

Team Lead, Global Regulatory Affairs x 2

The Team Lead, Global Regulatory Affairs CMC - Biological & Non-Biol. Products is responsible for:

Partnering closely with CSL’s R&D, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the assigned product portfolio.

Defining global regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s biological & non-biol. products.

Represent CSL in official regulatory CMC capacities, acting as an authorized official or responsible person in interactions with regulatory agencies.

This role promotes strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions...