Lead the global regulatory CMC strategy across the assigned development and commercial biological & non-biol. product portfolio, collaborating closely with cross-functional leaders
Job Summary
Lead the global regulatory CMC strategy across the assigned development and commercial biological & non-biol. product portfolio, collaborating closely with cross-functional leaders.
Manage the development and submission of high-quality, compliant CMC regulatory submissions and submission components, including new marketing applications, clinical trial applications, variations/supplements, periodic compliance reports and renewals.
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
Lead the global regulatory CMC strategy across the assigned development and commercial biological & non-biol. product portfolio, collaborating closely with cross-functional leaders.
Skills & Requirements
Must-have
Global regulatory CMC strategy
CMC regulatory submissions
Regulatory agency interactions
Cross-functional collaboration
Quality management system
Nice-to-have
Innovative regulatory approaches
Strong positive relationships with regulators
Driving operational efficiency
Culture of accountability and excellence
Key Requirements
Bachelor's degree in biological or chemical sciences
Over 5 years of progressive experience in regulatory roles