Global Head – Regulatory Affairs, Labeling

🕒 3 days ago

🇺🇸 United States – Remote

💵 $180k - $270k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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GE HealthCare

WebsiteLinkedInAll Job Openings

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 across development and marketed products • Align labeling strategy with TPP/TPL and commercial strategies to enable optimal indications, claims, and competitive positioning • Provide proactive feedback on clinical and CMC plans to shape endpoints, analyses, and evidence packages • Chair the Global Labeling Committee and Labeling Working Groups • Own CCDS creation, maintenance, and change control • Ensure timely and consistent global rollout across US, EU, China, Japan, and other markets • Establish and track labeling KPIs and drive continuous process improvement • Serve as principal labeling negotiator with FDA, EMA/NCAs, NMPA, PMDA, and other authorities • Lead labeling-focused meetings and written interactions to defend indications, populations, claims, dosing, warnings, and promotional language • Anticipate, mitigate, escalate, and resolve labeling risks • Partner with Market Access, Commercial, Medical, and Legal/Promo Review on label-to-launch readiness and compliant promotional scope • Translate complex regulatory concepts into executive narratives and influence senior stakeholders • Build and evolve the Global Labeling Center of Excellence, including governance, processes, metrics, inspection readiness, and systems • Ensure audit and inspection readiness and robust documentation • Provide leadership, alignment, and governance for consistency between labeling, promotional claims, product positioning, market access needs, and regulatory expectations

🎯 Requirements

• Minimum 10 years of experience leading Global Labeling in highly regulated pharmaceutical companies • Record of successful label negotiations and defense at FDA, EMA, NMPA, and PMDA • Strategic influence across Clinical, CMC, Medical, Market Access, and Commercial • Deep expertise in CCDS, core/product information, and global/local labeling execution, with US/EU experience at minimum • Exceptional negotiation and stakeholder management skills • Ability to craft precise, defensible labeling language from clinical data • Strong people leadership, including building high-performing teams, setting standards, and coaching labeling professionals and cross-functional contributors • Hands-on experience with Veeva RIM and labeling systems • Understanding of ePI evolution • Prior stewardship of a Global Labeling Committee/Working Group with measurable KPI improvement • Advanced degree in life sciences or pharmacy is desired • Market Access literacy to connect label language to reimbursement and promotional scope • Legally authorized to work in the United States • Successful completion of a drug screen, as applicable • GE HealthCare will not sponsor employment visas for this opening

🏖️ Benefits

• Medical, dental, and vision insurance • Paid time off • 401(k) plan with employee and company contribution opportunities • Life, disability, and accident insurance • Tuition reimbursement • Professional development • Challenging careers • Competitive compensation • Performance-based incentive compensation, which may include cash bonuses and/or long-term incentives (LTI)