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 strategy
CMC regulatory submissions
change control assessments
regulatory agency interactions
cross-functional collaboration
Nice-to-have
innovative regulatory approaches
strong positive relationships with regulators
operational excellence
driving engagement
global perspective
Key Requirements
Bachelor's degree in biological or chemical sciences
Over 5 years of progressive experience in regulatory roles