Global Labelling Specialist
21 hours ago
London
We are currently supporting a global biopharmaceutical organisation in the search for a Global Labelling Specialist to join their UK-based Regulatory Affairs team. This role sits within Global Regulatory Affairs and plays a key part in ensuring that product labelling is accurate, compliant, and implemented effectively across global markets, supporting patient safety and regulatory compliance throughout the product lifecycle. Key Responsibilities • Support the development, maintenance, and implementation of global and regional labelling, including:, • Core Data Sheets (CDS/CCDS), • EU SmPCs, PILs, and Annexes, • US Prescribing Information (USPI), where applicable, • Manage labelling updates arising from variations, safety updates, health authority requests, and lifecycle activities, • Coordinate artwork and packaging changes, including annotation, review, and approval of labelling components, • Support linguistic review and translation activities to ensure alignment with approved English reference texts, • Maintain accurate labelling trackers and documentation within regulatory systems, • Work cross-functionally with Regulatory, Safety, Medical, Quality, Supply Chain, and external vendors, • Ensure compliance with global, EU, and UK labelling regulations and internal governance processes, • Support inspections, audits, and internal labelling process improvements as required About You • Degree in a scientific or life sciences discipline, • Proven experience in regulatory labelling within pharma or biotech, • Strong knowledge of EU and UK labelling requirements (QRD, SmPC, PIL, Article 61/63), • Exposure to global labelling environments (EU, US and/or international markets), • Experience with labelling lifecycle management, artwork coordination, and implementation, • Familiarity with regulatory systems such as Veeva Vault (RIM / QualityDocs), EDMS, artwork tools, or similar, • Highly organised, detail-oriented, and comfortable working across multiple products and timelines, • Able to work collaboratively in a matrix, global environment Nice to Have • Experience responding to health authority labelling comments, • US labelling exposure (FDA annotations, supplements), • Experience supporting launches or major labelling updates, • Previous experience in a global pharma or biotech organisation