Director, Sr. Global Regulatory Lead - Cardiorenal

Admincsl

Global regulatory strategy development
Health authority interaction experience
Team leadership in matrix environment
The role involves developing a global, integrated regulatory strategy with a patient-centric focus to achieve successful outcomes from early development through post-marketing lifecycle activities

Job Summary

  • The role involves developing a global, integrated regulatory strategy with a patient-centric focus to achieve successful outcomes from early development through post-marketing lifecycle activities.
  • As the single GRA representative, the incumbent will lead health authority interactions with the FDA and EMA while managing the Global Regulatory Affairs Strategy Team.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives, utilizing plasma fractionation and recombinant protein technologies to address unmet medical needs.

Matching Summary

The role involves developing a global, integrated regulatory strategy with a patient-centric focus to achieve successful outcomes from early development through post-marketing lifecycle activities.

Skills & Requirements

Must-have

  • Global regulatory strategy development
  • Health authority interaction experience
  • Team leadership in matrix environment
  • Cardiorenal therapeutic area knowledge
  • Regulatory document preparation

Nice-to-have

  • Patient-centric focus approach
  • Innovative risk-taking mindset
  • Cross-functional collaboration skills
  • Talent development and mentoring
  • Strategic scientific platform knowledge

Key Requirements

  • Bachelor's degree in life sciences required
  • Minimum 10 years in biotech or pharma industry
  • At least 8 years in regulatory affairs
  • 5 years experience with developmental products
  • 5 years leading teams preferred

Work Rights

Not specified

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