Regulatory Affairs Manager

We are seeking a highly motivated Regulatory Affairs Associate/Manager to support a dynamic regulatory team on a portfolio of orphan pediatric medicinal products . This is a part‑time, flexible role, ideal for someone with experience in EMA and UK regulatory submissions and lifecycle management.

You will work across multiple products, supporting both centralised and national procedures , with exposure to orphan drug designations (ODD) and Pediatric Investigation Plans (PIPs) .

This is an exciting opportunity to join a supportive and collaborative team , with guidance and onboarding provided to help you quickly get up to speed.

Key Responsibilities

• Support preparation, review, and submission of EMA and UK regulatory dossiers
• Assist with lifecycle management activities: variations, renewals, and post‑approval updates
• Contribute to ODD and PIP submissions and related documentation
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