Global Regulatory Lead, Pharmaceutical Diagnostics

GE HealthCare UK

Base: $153,600.00-$230,400.00 annual; bonus/equity...
Not specified (assumed to be hybrid or onsite based on company practices).
7+ years regulatory experience in pharmaceutical field
Leading us nda/bla licensing submissions
Pan european regulatory submission expertise
GE HealthCare is seeking a Global Regulatory Lead for its Pharmaceutical Diagnostics sector, responsible for overseeing regulatory strategies for new product introductions related to medical imaging. The ideal candidate should have extensive experience in regulatory affairs within the pharmaceutical industry and a proven track record of successful submissions to regulatory agencies

Job Summary

  • This role serves as the single point of accountability for Global Regulatory Strategy Leadership and policy development for pharmaceutical diagnostics products.
  • The successful candidate will lead global program development strategies ensuring timely input for US NDA/BLA and Pan European submissions.
  • GE HealthCare offers a competitive benefits package including medical, dental, vision, paid time off, and a 401(k) plan with company contributions.

Matching Summary

Match Score: 85

GE HealthCare is seeking a Global Regulatory Lead for its Pharmaceutical Diagnostics sector, responsible for overseeing regulatory strategies for new product introductions related to medical imaging. The ideal candidate should have extensive experience in regulatory affairs within the pharmaceutical industry and a proven track record of successful submissions to regulatory agencies.

Salary

Base: $153,600.00-$230,400.00 Annual; Bonus/Equity: Performance based incentive compensation eligible; Benefits: Medical, dental, vision, 401(k), life, disability insurance

Skills & Requirements

Must-have

  • 7+ years regulatory experience in pharmaceutical field
  • Leading US NDA/BLA licensing submissions
  • Pan European regulatory submission expertise
  • Clinical related regulations guidance knowledge
  • Stakeholder influence and motivation skills

Nice-to-have

  • Knowledge of preclinical and CMC development
  • Ability to drive new regulatory approaches
  • Experience with global regulatory strategy documents
  • Proven track record with agency interactions

Key Requirements

  • Bachelor's Degree in Science, Biotech, or Engineering
  • 7+ years of experience in regulatory affairs
  • Legal authorization to work in the United States
  • No visa sponsorship provided for this position

Work Rights

Must be legally authorized to work in the United States

Tailored Resume

Cover Letter