Global Labelling Lead - EU US Regulatory Affairs

12-Month Contract | Remote/Hybrid UK We are seeking an experienced Global Labelling Lead to support global regulatory labelling activities across the US and EU markets.

Key Responsibilities:

Lead global labelling strategy and execution across product life cycle activities. Manage Core Data Sheets (CDS), Company Core Safety Information (CCSI) and associated labelling documentation. Evaluate and implement labelling updates in line with US and EU regulatory requirements. Support Target Label Profile (TLP) development and maintenance. Partner with Regulatory Affairs, Safety, Clinical and Medical Affairs teams to deliver compliant labelling outcomes.

Assess regulatory impacts and drive timely submissions and labelling changes. Requirements:
Extensive experience in pharmaceutical regulatory affairs with a strong focus on global labelling. Proven expertise supporting US (FDA) and EU (EMA) labelling activities. Experience developing and maintaining Target Label Profiles (TLPs). Strong knowledge of product lifecycle management and regulatory compliance. Excellent stakeholder management and communication skills. For more information or to apply, please get in touch.