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GE HealthCare

Global Regulatory Lead, PDx

GE HealthCare

. Lead assigned global program development regulatory strategy and co-ordinate with National Regulatory Affairs (NRA) regulatory submission readiness .

Posted 3/31/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $153,600 - $230,400 per yearWebsite

About the role

Key responsibilities & impact
  • Lead assigned global program development regulatory strategy and co-ordinate with National Regulatory Affairs (NRA) regulatory submission readiness
  • Working with NRA, ensure timely GRA input to global development programs
  • For assigned programs/projects, identify regulatory opportunities, potential risks, and mitigations
  • Guide, influence and motivate, internal and external stakeholders to meet GE HealthCare business and development project team objectives
  • Fulfillment of RA compliance obligations

Requirements

What you’ll need
  • Bachelor’s Degree in Science, Biotech, Engineering or related field
  • 7+ years of experience in regulatory, preferably in the pharmaceutical field
  • Proven track record of leading successful US NDA/BLA licensing submissions and Pan European (CP, DCP, MRP), European national
  • Proven track record of leading successful interaction with regulatory agencies and relevant stakeholders
  • Proven expertise with clinical related regulations/guidance as it relates to development of product submissions
  • Ability to clearly convey and exchange information with internal and external stakeholders

Benefits

Comp & perks
  • medical
  • dental
  • vision
  • paid time off
  • 401(k) plan with employee and company contribution opportunities
  • life
  • disability
  • accident insurance
  • tuition reimbursement

ATS Keywords

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Hard Skills & Tools
regulatory strategyregulatory submission readinessNDA licensing submissionsBLA licensing submissionsCPDCPMRPclinical regulationsproduct submissions
Soft Skills
leadershipinfluencemotivationcommunicationstakeholder engagement
Certifications
Bachelor’s Degree in ScienceBachelor’s Degree in BiotechBachelor’s Degree in Engineering