Associate Director, Regulatory Affairs – UK & Ireland

Overview

In this role you will lead UK regulatory strategy and the RA team to secure and maintain marketing authorizations for programs across development, registration, and lifecycle. You will coordinate with cross‑functional stakeholders to implement UK MAA strategies and ensure compliance for UK and Ireland. You will manage regulatory dossiers, agency communications, and labeling updates, while mitigating risks and shaping regulatory policy in oncology. This position offers visibility with business leadership and opportunities to influence product approvals and lifecycle management in a fast‑growing oncology company.

Responsibilities

• Define and implement UK MAA strategy aligned with development objectives
• Prepare and manage UK MAA regulatory dossiers
• Support labeling updates and Ireland regulatory requirements
• Oversee regulatory agency communications, submissions, and approvals with focus on first‑cycle approvals
• Lead UK Leadership team discussions and act as MHRA liaison for strategic topics
• Prepare team for HA interactions and support EU RA clinical regulatory matters
• Proactively identify regulatory risks and provide mitigation plans
• Ensure EU/UK regulatory compliance across programs
• Mentor junior regulatory staff
• Represent BeOne at UK industry associations and congresses

Key requirements

• Bachelor’s degree in an appropriate field
• Minimum 8 years in biopharma/biotech with at least 8 years in Regulatory affairs
• Mandatory experience with MHRA regulatory procedures
• Solid understanding of drug development and UK regulatory landscape
• Recent oncology MAAs, ODD, PIP experience preferred
• Ability to deliver goals in cross‑functional environments
• Professionalism and strong stakeholder management

• collaboration
• leadership and mentorship
• proactivity
• Veeva Regulatory Publishing
• Microsoft Office suite
• PowerPoint for presentations

…