GE HealthCare · 8 hours ago
Global Head, Regulatory Affairs – Labeling (PDx)
United States
Full-time
Remote
Director/Executive
$173K/yr - $259K/yr
10+ years expGE HealthCare is a leading global medical technology and digital solutions innovator. The Global Head, Regulatory Affairs – Labeling is responsible for setting the enterprise labeling vision and delivering the strategic labeling agenda across PDx, ensuring compliance and optimal product positioning through effective labeling strategies and agency negotiations.
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No H1B
U.S. Citizen Only
Responsibilities
Lead the global labeling strategy for all PDx products (development and marketed), aligning with TPP/TPL and commercial strategies to enable optimal indications, claims, and competitive positioning
Provide early, proactive feedback on clinical and CMC plans (Phase I–III and LCM) to shape endpoints, analyses, and evidence packages that unlock the best label and access outcomes
Chair the Global Labeling Committee and Labeling Working Groups, driving crisp decisions, risk/benefit trade‑offs, and cross‑functional alignment
Own CCDS creation, maintenance, and change control; ensure timely, consistent roll‑out into US, EU, China, Japan and other markets, with documented exceptions and transparent rationale
Establish and track labeling KPIs (e.g., cycle times, first‑pass acceptance, variation close‑out, deviation rate) and drive continuous improvement across processes, templates, and training
Serve as the principal labeling negotiator with FDA, EMA/NCAs, NMPA (China), PMDA (Japan) and other authorities; lead labeling‑focused meetings and written interactions to defend indication, population, claims, dosing, warnings, and promo‑relevant language
Anticipate and mitigate labeling risks that lead to CRLs, REMS/PMR/PMC obligations, or restrictive language; escalate and resolve issues decisively
Partner with Market Access, Commercial, Medical, and Legal/Promo Review to ensure label‑to‑launch readiness and compliant promotional scope aligned to positioning and payer needs
Translate complex regulatory concepts into clear executive narratives; influence senior stakeholders on evidence/label trade‑offs and go‑to‑market implications
Build and evolve the Global Labeling Center of Excellence, including governance, end‑to‑end processes, metrics, inspection readiness, and systems (e.g., Veeva RIM, ePI)
Ensure audit/inspection readiness and robust documentation across labeling decisions, deviations, and exceptions
Work with the Global Head RA, Ad Promo to provide the overarching leadership, alignment, and governance needed to ensure consistency between labeling, promotional claims, product positioning, market access needs, and global regulatory expectations
Qualification
Required
Minimum 10 years of experience leading Global Labeling in a highly regulated pharmaceutical companies, with a record of successful label negotiations and defense at FDA/EMA/NMPA/PMDA
Demonstrated strategic influence across Clinical, CMC, Medical, Market Access, and Commercial to shape development and lifecycle plans toward best‑possible labeling and access
Deep expertise in CCDS, core/product information, and global/local labeling execution (US/EU at minimum)
Exceptional negotiation and stakeholder management skills, internally and externally; proven ability to craft precise, defensible labeling language from clinical data
Strong people leadership: building high‑performing teams, setting standards, and coaching labeling professionals and cross‑functional contributors
Preferred
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; Market Access literacy to connect label language to reimbursement and promo scope
Benefits
Medical
Dental
Vision
Paid time off
A 401(k) plan with employee and company contribution opportunities
Life
Disability
Accident insurance
Tuition reimbursement
Company
GE HealthCare
GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.52BKey Investors
Bill & Melinda Gates Foundation
2024-11-07Post Ipo Secondary· $1.17B
2024-09-12Post Ipo Secondary· $1.29B
2024-02-16Post Ipo Secondary· $1.07B
Leadership Team
Catherine Estrampes
President and CEO, US & Canada
Luiz Verzegnassi
President & CEO, Services
Recent News
2026-01-16
Medical Device Network
2026-01-16
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