Global Regulatory Lead, Pdx

GEHC

Remote
Base: $153,600.00-$230,400.00 annual; bonus/equity...
Global program development regulatory strategy
Regulatory submission readiness
Gra input to global development programs
As a Global Regulatory Lead, you will contribute to the development, from pre-clinical through clinical studies to initial registration in key global markets, of pharmaceutical diagnostics

Job Summary

  • As a Global Regulatory Lead, you will contribute to the development, from pre-clinical through clinical studies to initial registration in key global markets, of pharmaceutical diagnostics.
  • You will be ‘the face’ of the Global Regulatory function on cross-functional global project teams for new product introductions and single point of accountability for Global Regulatory Strategy Leadership and policy development.
  • Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities.

Matching Summary

As a Global Regulatory Lead, you will contribute to the development, from pre-clinical through clinical studies to initial registration in key global markets, of pharmaceutical diagnostics.

Salary

Base: $153,600.00-$230,400.00 Annual; Bonus/Equity: Performance based incentive compensation, cash bonus(es) and/or long term incentives (LTI); Benefits: Medical, dental, vision, paid time off, 401(k) plan, life, disability, accident insurance, tuition reimbursement

Skills & Requirements

Must-have

  • Global program development regulatory strategy
  • Regulatory submission readiness
  • GRA input to global development programs
  • Identify regulatory opportunities and risks
  • Lead interaction with regulatory agencies

Nice-to-have

  • Drive new regulatory approaches
  • Act with humility and build trust
  • Lead with transparency
  • Deliver with focus
  • Drive ownership with unyielding integrity

Key Requirements

  • Bachelor’s Degree in Science, Biotech, Engineering or related field
  • 7+ years in regulatory, preferably pharmaceutical
  • Proven track record of leading successful US NDA/BLA licensing submissions
  • Proven track record of leading successful Pan European submissions
  • Proven expertise with clinical related regulations/guidance
  • Ability to clearly convey and exchange information

Work Rights

Legally authorized to work in the United States

Tailored Resume

Cover Letter