Medasource

Compensation

Full Description

Global Labeling Lead About the Role As a Global Labeling Lead, you’ll be at the forefront of regulatory labeling, ensuring our products are supported by clear, compliant, and high-quality documentation. You’ll lead cross-functional teams and collaborate globally to deliver core, EU and US labeling that meets regulatory standards and supports safe product use across markets. What You’ll Do • Labeling Strategy & Development • Lead creation and management of labeling documents (CDS, USPI, EU SmPC, Global Patient Leaflet, Target Label Profile) across the product lifecycle • Drive alignment on labeling content and strategy across EU, US, and global teams • Develop contingency wording for Health Authority queries in collaboration with subject matter experts • Ensure timely endorsement of labeling decisions by senior leadership • Operational Oversight • Oversee operational labeling activities including EU/US artwork coordination, EMA linguistic reviews, US SPL submissions • Maintain labeling documentation in EDMS and regulatory tracking systems • Global Implementation & Compliance • Support regional rollout of CDS updates and monitor compliance • Collaborate with regional and local regulatory leads to address Health Authority queries and track country-specific labeling differences • Maintain version control and ensure audit readiness through SOPs and process updates • Strategic Labeling Expertise • Interpret clinical data to inform labeling content and product claims • Identify risks and opportunities in labeling strategy and guide cross-functional teams • Stay current on global labeling regulations and provide training to internal stakeholders What You Bring • 5+ years within regulatory in the pharmaceutical/biotech industry, including strategic regulatory labeling • Strong understanding of global labeling regulations and systems (EDMS, regulatory tracking, artwork/supply chain tools) • Proven ability to lead cross-functional teams and influence across cultures • Excellent communication, organization, and stakeholder engagement skills • Bachelor’s degree in a scientific or medical discipline