The role involves leading the global regulatory CMC strategy across a portfolio of biological and non-biological products while collaborating with cross-functional leaders
Job Summary
The role involves leading the global regulatory CMC strategy across a portfolio of biological and non-biological products while collaborating with cross-functional leaders.
Candidates will represent CSL in official regulatory capacities as an authorized official or responsible person during interactions with regulatory agencies.
The position offers the opportunity to join an agile team committed to developing vaccines that make a meaningful difference worldwide.
Matching Summary
The role involves leading the global regulatory CMC strategy across a portfolio of biological and non-biological products while collaborating with cross-functional leaders.
Skills & Requirements
Must-have
Global regulatory CMC strategy leadership
Biologics and non-biological product submissions
Regulatory agency interaction and representation
Change control assessment in quality management system
Cross-functional collaboration with R&D and Quality
Nice-to-have
Innovative regulatory approaches for competitive positioning
Strategic problem solving and contingency planning
Strong relationship management with health authorities
Key Requirements
Bachelor's degree in biological or chemical sciences required
Over 5 years of progressive experience in biologics or plasma industry