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GE HealthCare

Director, Regulatory Affairs – Market Products, Radiopharma

GE HealthCare

Director of Regulatory Affairs leading lifecycle management of radiopharmaceutical products at GE HealthCare. Ensuring regulatory compliance and strategic leadership while collaborating globally.

Posted 6/26/2026full-timeRemote • 🇺🇸 United StatesLead💰 $153,600 - $230,400 per yearWebsite

About the role

Key responsibilities & impact
  • Define and drive the global lifecycle regulatory strategy aligned with corporate, portfolio, and product objectives
  • Act as a strategic partner to senior leadership, communicating risks, opportunities, and regulatory scenarios
  • Lead, coach, and develop a high-performing global regulatory team
  • Oversee all post-approval regulatory activities, including variations, renewals, and regulatory commitments
  • Lead regulatory strategy for post-approval changes, including impact assessment, pathway optimization, and risk mitigation
  • Ensure compliance with global regulatory requirements and evolving health authority expectations
  • Partner with RA-CMC to align regulatory strategies for technical and manufacturing changes
  • Ensure timely, high-quality execution of lifecycle submissions through effective planning, tracking, and team accountability

Requirements

What you’ll need
  • Bachelor’s or advanced degree in Life Sciences, Pharmacy, Chemistry, or related field
  • 7+ years of regulatory affairs experience with strong focus on post-approval lifecycle management
  • Proven experience working in cross-functional global environments
  • Leadership experience managing teams
  • Strong strategic, communication, and stakeholder management skills

Benefits

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
regulatory strategylifecycle managementpost-approval activitiesimpact assessmentpathway optimizationrisk mitigationcomplianceregulatory submissionsteam accountability
Soft Skills
leadershipcoachingcommunicationstakeholder managementstrategic thinking
Certifications
Bachelor’s degreeadvanced degree