Director, Sr. Global Regulatory Lead - Cardiorenal

Chlworks

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 succession planning
  • Inclusion and Belonging culture

Key Requirements

  • Bachelor’s degree in life science
  • 10+ years in biotech/pharma
  • 8+ years in regulatory affairs
  • 5+ years with developmental products
  • 5+ years leading teams
  • Knowledge of EU, US, Japan regulatory requirements
  • Direct health authority interaction experience

Work Rights

Not specified

Tailored Resume

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