The Team Lead, Global Regulatory Affairs CMC is responsible for defining global regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s biological & non-biol. products
Job Summary
The Team Lead, Global Regulatory Affairs CMC is responsible for defining global regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s biological & non-biol. products.
This role promotes strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL’s strategic business objectives.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies.
Matching Summary
The Team Lead, Global Regulatory Affairs CMC is responsible for defining global regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s biological & non-biol. products.
Skills & Requirements
Must-have
Global regulatory strategy
CMC regulatory submissions
Regulatory agency interactions
Cross-functional collaboration
Change control assessments
Nice-to-have
Innovative regulatory approaches
Strong positive relationships with regulators
Operational excellence
Culture of accountability and excellence
Inclusion and Belonging
Key Requirements
Bachelor's degree in biological or chemical sciences
Over 5 years of progressive experience
Advanced degree strongly preferred
Experience in biologics or plasma industry
Proven expertise in authoring, reviewing, and managing submissions