Medasource
Overview
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
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 Seniority level
Mid-Senior level Employment type
Full-time
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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
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 Seniority level
Mid-Senior level Employment type
Full-time
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