Senior Regulatory Affairs Associate, EU & UK Market

Overview

In this role you will support lifecycle management of a diverse generic portfolio, preparing and submitting regulatory dossiers to MHRA and EMA, and guiding post-approval activities. You will liaise with authorities, manage labeling compliance, and contribute to regulatory strategy while tracking timelines and guidelines. Join a collaborative, growth-focused team delivering affordable medicines across UK and EU markets.

Pay / Benefits

• Hybrid working (3 days onsite, 2 days remote)
• Career development and ongoing training
• Collaborative team environment
• Exposure to broad generics portfolio across UK and EU

Responsibilities

• Manage lifecycle activities for a portfolio of generic medicines
• Prepare and submit regulatory dossiers (MAAs, variations, renewals) per MHRA/EMA requirements
• Oversee post-approval activities and ongoing compliance
• Liaise with regulatory authorities and respond to queries within timelines
• Ensure labeling and documentation (SmPCs, PILs, artwork) compliance
• Support regulatory strategy and monitor evolving guidelines impact
• Track submission timelines and project manage multiple filings

Key requirements

• Degree in Life Sciences, Pharmacy, or a related field
• Regulatory Affairs experience in pharma (generics preferred)
• Knowledge of UK MHRA and EU regulatory frameworks
• Experience with CTD/eCTD submissions and lifecycle management
• Familiarity with variations and post-approval processes
• Excellent organisational and communication skills
• Ability to manage multiple projects in a fast-paced environment

• Strong organizational skills
• Effective communication
• Multi-project management
• CTD/eCTD submissions
• UK MHRA and EU regulatory frameworks
• Variations and post-approval processes

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