Global Head, Regulatory Affairs – Labeling

🕒 il y a 14 jours

🇺🇸 États-Unis – Télétravail

💵 $180 000 - $270 000 / an

⏰ Temps Plein

🔴 Expert

🚔 Conformité

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GE HealthCare

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1892

💊 Pharmaceutique

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare est un leader des soins de précision, dédié à fournir des technologies innovantes et des solutions intégrées qui améliorent les services de santé. En tant qu'entreprise autonome, elle se concentre sur l'imagerie, l'échographie et les technologies de l'information en santé, permettant aux cliniciens d'améliorer les résultats pour les patients grâce à des technologies médicales avancées et des solutions de soins personnalisées. Avec un investissement significatif en recherche et développement, GE HealthCare vise à transformer les soins de santé en rendant les hôpitaux plus efficaces et les thérapies plus précises.

Description

• Lead the global labeling strategy for all PDx products (development and marketed) • 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.

🎯 Exigences

• 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 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.

🏖️ Avantages

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