Director, Sr. Global Regulatory Lead - Cardiorenal

Seqirus

Ch, , CH
Global regulatory strategy development
Health authority interactions fda ema
Leadership of regulatory affairs teams
The Director, Senior Global Regulatory Lead contributes to CSL's vision by developing innovative and scientifically sound global regulatory strategies with a patient-centric focus

Job Summary

  • The Director, Senior Global Regulatory Lead contributes to CSL's vision by developing innovative and scientifically sound global regulatory strategies with a patient-centric focus.
  • This role leads health authority interactions, fosters collaboration across global teams, and ensures alignment of regulatory strategies throughout the product lifecycle.
  • CSL Behring is a global biotherapeutics leader committed to innovation and inclusion, offering a diverse and supportive work environment.

Matching Summary

The Director, Senior Global Regulatory Lead contributes to CSL's vision by developing innovative and scientifically sound global regulatory strategies with a patient-centric focus.

Skills & Requirements

Must-have

  • Global regulatory strategy development
  • Health authority interactions FDA EMA
  • Leadership of regulatory affairs teams
  • Cross-functional team collaboration
  • Regulatory document preparation
  • Product development regulatory knowledge

Nice-to-have

  • Patient-centric regulatory focus
  • Mentoring and coaching skills
  • Experience in complex matrix environments
  • Talent development and succession planning
  • Knowledge sharing and collaboration promotion

Key Requirements

  • Bachelor’s degree in life sciences
  • Advanced degree preferred
  • Minimum 10 years biotech/pharma experience
  • At least 8 years regulatory affairs experience
  • 5 years experience with developmental products
  • 5 years leadership experience
  • Experience with major regional regulatory requirements
  • Direct interaction with health authorities

Work Rights

Not specified

Tailored Resume

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