Director, Sr. Global Regulatory Lead - Cardiorenal

CSL Behring

Ch, United States
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 to discover, develop and deliver innovative therapies.

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 affairs experience
  • Biotech or pharmaceutical industry

Nice-to-have

  • Patient-centric focus
  • Risk-taking for regulatory outcomes
  • Talent development and succession planning
  • Inclusion and Belonging culture
  • Innovative solution development

Key Requirements

  • Minimum 10 years in biotech or pharmaceutical industry
  • At least 8 years in regulatory affairs
  • At least 5 years with developmental products
  • Experience leading teams (preferably 5 years)
  • Knowledge of product development and regulatory requirements across major regions (EU, US, Japan)
  • Experience interacting directly with at least one health authority

Work Rights

Not specified

Tailored Resume

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