Global Labelling Lead - EU US Regulatory Affairs
| Company: | Hays Specialist Recruitment |
|---|---|
| Salary: | Not specified |
| Hours: | Full-time |
| Location: | Maidenhead, EC2V 6DB |
| Job type: | Contract |
| Posting date: | 17 Sept 2026 |
| Closing date: | 24 Sept 2026 |
Summary
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.
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