Director, Sr. Global Regulatory Lead - Cardiorenal
CSL Behring
Global regulatory strategy development
Health authority interactions (fda, ema)
Product strategy team leadership
Develops a global, integrated regulatory strategy ensuring innovative and scientifically sound regulatory approaches for assigned products, with a patient-centric focus and appropriate risk-taking to achieve successful regulatory outcomes from early development through post-marketing lifecycle activities
Job Summary
Develops a global, integrated regulatory strategy ensuring innovative and scientifically sound regulatory approaches for assigned products, with a patient-centric focus and appropriate risk-taking to achieve successful regulatory outcomes from early development through post-marketing lifecycle activities.
Leads health authority interactions (FDA, EMA) and builds productive relationships to drive positive regulatory outcomes globally.
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
Develops a global, integrated regulatory strategy ensuring innovative and scientifically sound regulatory approaches for assigned products, with a patient-centric focus and appropriate risk-taking to achieve successful regulatory outcomes from early development through post-marketing lifecycle activities.
Skills & Requirements
Must-have
Global regulatory strategy development
Health authority interactions (FDA, EMA)
Product Strategy Team leadership
Regulatory lifecycle management
Cross-functional team collaboration
Nice-to-have
Patient-centric focus
Risk-taking for regulatory outcomes
Talent development and succession planning
Innovative regulatory solutions
Inclusion and Belonging culture
Key Requirements
Minimum 10 years biotech/pharma industry
At least 8 years regulatory affairs
5 years developmental products experience
5 years team leadership experience
Knowledge of EU, US, Japan regulatory requirements