GE HealthCare
10,000+ employees
Founded 1892
🏥 Healthcare
💊 Pharmaceuticals
Healthcare • Medical Technology • Pharmaceuticals
GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.
Global Head, Regulatory Affairs – Labeling
🕒 July 10
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GE HealthCare
10,000+ employees
Founded 1892
🏥 Healthcare
💊 Pharmaceuticals
Healthcare • Medical Technology • Pharmaceuticals
GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.
📋 Description
• Lead the global labeling strategy for all PDx products • Provide early, proactive feedback on clinical and CMC plans • Chair the Global Labeling Committee and Labeling Working Groups • Own CCDS creation, maintenance, and change control • Serve as the principal labeling negotiator with FDA, EMA/NCAs, NMPA (China), PMDA (Japan) • Partner with Market Access, Commercial, Medical, and Legal/Promo Review • Build and evolve the Global Labeling Center of Excellence • Work with the Global Head RA, Ad Promo for consistency between labeling and promotional claims
🎯 Requirements
• Minimum 10 years of experience leading Global Labeling in a highly regulated pharmaceutical companies • Demonstrated strategic influence across Clinical, CMC, Medical, Market Access, and Commercial • Deep expertise in CCDS, core/product information, and global/local labeling execution (US/EU at minimum) • Exceptional negotiation and stakeholder management skills • Strong people leadership
🏖️ Benefits
• medical, dental, vision • paid time off • 401(k) plan with employee and company contribution opportunities • life, disability, and accident insurance • tuition reimbursement
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