Director, Sr. Global Regulatory Lead - Cardiorenal
Cslbehring Com Au
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.
Acts as a key member and single GRA representative for Product Strategy Teams (PST) and related global R&D/commercial teams, while leading the Global Regulatory Affairs Strategy Team (GRAST) to ensure alignment and a unified regulatory voice.
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 intelligence and analytics
Cross-functional team collaboration
Nice-to-have
Patient-centric focus
Risk-taking for regulatory outcomes
Talent development and team empowerment
Inclusion and belonging culture
Key Requirements
Minimum 10 years in biotech/pharma
At least 8 years in regulatory affairs
5 years with developmental products
5 years leading teams
Knowledge of EU, US, Japan regulatory requirements