The Team Lead is responsible for partnering closely with R&D, Manufacturing, Quality, and Regulatory Affairs stakeholders to deliver innovative and timely regulatory solutions that meet evolving CMC regulatory and compliance requirements
Job Summary
The Team Lead is responsible for partnering closely with R&D, Manufacturing, Quality, and Regulatory Affairs stakeholders to deliver innovative and timely regulatory solutions that meet evolving CMC regulatory and compliance requirements.
This role promotes strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other business functions to support CSL’s strategic business objectives.
CSL Behring is a global biotherapeutics leader focused on using the latest technologies to develop and deliver innovative therapies for patients worldwide, supported by a large plasma collection network and a diverse workforce.
Matching Summary
The Team Lead is responsible for partnering closely with R&D, Manufacturing, Quality, and Regulatory Affairs stakeholders to deliver innovative and timely regulatory solutions that meet evolving CMC regulatory and compliance requirements.
Skills & Requirements
Must-have
Global regulatory CMC strategy
Regulatory submissions management
Cross-functional team leadership
Compliance with international standards
Change control assessments
Regulatory agency interactions
Nice-to-have
Innovative regulatory approaches
Mentoring and team motivation
Effective communication skills
Collaborative cross-functional work
Strategic regulatory planning
Problem solving and contingency planning
Global perspective
Key Requirements
Bachelor’s degree in biological or chemical sciences
Advanced degree preferred (MS, PhD)
Over 5 years regulatory experience in biologics or plasma industry