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 general 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.

JBRP1_UKTJ

📌 Global Labelling Lead (España)
🏢 Hays
📍 España