Director, Sr. Global Regulatory Lead - Cardiorenal

CSL Behring

Global regulatory strategy development
Health authority interaction experience
Team leadership in matrix environment
The role involves developing a global, integrated regulatory strategy ensuring innovative approaches for assigned products with a patient-centric focus

Job Summary

  • The role involves developing a global, integrated regulatory strategy ensuring innovative approaches for assigned products with a patient-centric focus.
  • Candidates will act as the single GRA representative for Product Strategy Teams while leading the Global Regulatory Affairs Strategy Team to ensure alignment.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives using advanced technologies across multiple therapeutic areas.

Matching Summary

The role involves developing a global, integrated regulatory strategy ensuring innovative approaches for assigned products with a patient-centric focus.

Skills & Requirements

Must-have

  • Global regulatory strategy development
  • Health authority interaction experience
  • Team leadership in matrix environment
  • Product development lifecycle knowledge
  • Regulatory document preparation

Nice-to-have

  • Patient-centric focus approach
  • Innovative risk-taking mindset
  • Cross-functional collaboration skills
  • Talent development and mentoring
  • Knowledge sharing promotion

Key Requirements

  • Bachelor's degree in life science required
  • Minimum 10 years in biotech or pharma industry
  • At least 8 years in regulatory affairs
  • 5 years with developmental products
  • 5 years of team leadership experience
  • Direct interaction with FDA or EMA

Work Rights

Not specified

Tailored Resume

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