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, ensuring timely execution aligned with regulatory expectations and business goals.
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
Change control assessments
Interactions with regulatory agencies
Cross-functional collaboration
Nice-to-have
Innovative regulatory approaches
Strong positive relationships with regulators
Motivating and mentoring diverse teams
Adaptability to evolving business needs
Key Requirements
Bachelor's degree in biological or chemical sciences
Over 5 years of progressive experience in regulatory roles
Strong technical foundation with in-depth knowledge of global regulations
Proven expertise in authoring, reviewing, and managing regulatory submissions