Lead Counsel Regulatory, Safety & Phv

CSL BEHRING

PA, United States
Government regulator interactions
Regulatory submission strategies
Biological regulations knowledge
Acts as a leader with government regulator interactions and provides development and implementation strategies for timely submission and approval of various applications

Job Summary

  • Acts as a leader with government regulator interactions and provides development and implementation strategies for timely submission and approval of various applications.
  • Provides counsel to and manages a regulatory sub-function, ensuring timely preparation of scientifically valid applications and expertise in translating regulatory requirements.
  • Maintains a strong collaborative relationship across CSL sites, including site communications, knowledge sharing, and good working relationships with all stakeholders.

Matching Summary

Acts as a leader with government regulator interactions and provides development and implementation strategies for timely submission and approval of various applications.

Skills & Requirements

Must-have

  • government regulator interactions
  • regulatory submission strategies
  • biological regulations knowledge
  • cross-site collaboration

Nice-to-have

  • patient-focused innovation
  • diverse and inclusive culture
  • lifesaving therapies

Key Requirements

  • 12+ years pharmaceutical industry experience
  • 8+ years Global Regulatory Affairs experience
  • 10+ years leadership experience
  • Advanced degree in Life Science or Business

Work Rights

Not specified

Tailored Resume

Cover Letter