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