Global Head, Regulatory Affairs – Labeling (PDx)

GE HealthCare

5d

About The Position

The Global Head, Regulatory Affairs – Labeling sets the enterprise labeling vision and delivers the strategic labeling agenda across PDx: from target product profile (TPP) and target product labeling (TPL) through Company Core Data Sheet (CCDS) stewardship and global implementation. This leader ensures that labeling is a core lever for product positioning and market access, translating clinical and CMC evidence into precise, defensible labeling language that differentiates our portfolio and enables compliant promotion and reimbursement. The role owns the end to end global labeling framework, governance, metrics, and systems, and leads high stakes agency negotiations to defend labeling and secure optimal indications and claims. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• Strategic Labeling & Product Positioning 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.
• CCDS Ownership & Global Implementation 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.
• Agency Engagement & Negotiation 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.
• Cross‑Functional Influence & Commercial Enablement 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.
• Operating Model, Systems & Compliance 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.
• Ad Promo Oversight 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.

Benefits

• GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees