Director, Sr. Global Regulatory Lead - Cardiorenal

CSL Behring

Not specified
10 years biotech or pharmaceutical industry experience
8 years regulatory affairs experience
5 years developmental product experience
CSL Behring is seeking a Director, Senior Global Regulatory Lead for its Global Regulatory Strategy team. This position involves developing and executing innovative regulatory strategies for cardiorenal products, leading health authority interactions, and managing a team to ensure successful regulatory outcomes

Job Summary

  • The role involves developing a global, integrated regulatory strategy ensuring innovative approaches for assigned products with a patient-centric focus.
  • The incumbent acts as the single GRA representative for Product Strategy Teams and leads the Global Regulatory Affairs Strategy Team to ensure alignment.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies across multiple therapeutic areas.

Matching Summary

Match Score: 85

CSL Behring is seeking a Director, Senior Global Regulatory Lead for its Global Regulatory Strategy team. This position involves developing and executing innovative regulatory strategies for cardiorenal products, leading health authority interactions, and managing a team to ensure successful regulatory outcomes.

Skills & Requirements

Must-have

  • 10 years biotech or pharmaceutical industry experience
  • 8 years regulatory affairs experience
  • 5 years developmental product experience
  • FDA and EMA interaction experience
  • Leading cross-functional global teams

Nice-to-have

  • Experience in complex matrix environment
  • Advanced degree in life sciences or MBA
  • Mentoring and talent development skills
  • Patient-centric regulatory approach
  • Strategic risk-taking capabilities

Key Requirements

  • Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science
  • Minimum 10 years in biotech or pharmaceutical industry
  • At least 5 years of team leadership experience
  • Knowledge of regulatory requirements across EU, US, and Japan

Work Rights

Not specified

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