Lead Counsel Regulatory, Safety & Phv

cslbehring.ch

Government regulator interactions
Regulatory submission strategies
Biological regulations knowledge
Acts as a leader with government regulator interactions and provides development and may lead implementation strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc

Job Summary

  • Acts as a leader with government regulator interactions and provides development and may lead implementation strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc.
  • Provides counsel to and manages a regulatory sub-function; ensures timely preparation of organized and scientifically valid applications; provides expertise in translating regulatory requirements into practical, workable plans.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies.

Matching Summary

Acts as a leader with government regulator interactions and provides development and may lead implementation strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc.

Skills & Requirements

Must-have

  • government regulator interactions
  • regulatory submission strategies
  • biological regulations knowledge
  • stakeholder relationship management
  • regulatory compliance assurance

Nice-to-have

  • collaboration across sites
  • knowledge sharing
  • inclusion and belonging culture
  • scientific innovation

Key Requirements

  • 12+ years pharmaceutical industry experience
  • 8+ years Global Regulatory Affairs experience
  • 10+ years leadership experience
  • Advanced degree in Life Science or Business
  • Post graduate qualification (PhD, MD, MBA or other)

Work Rights

Not specified

Tailored Resume

Cover Letter