Senior Regulatory Affairs Associate, EU Market

Your new company

An established, research-driven generics pharmaceutical company with a strong presence across the UK and EU markets. The organisation offers a collaborative, team-oriented environment and is committed to delivering high-quality, affordable medicines while supporting employee development.

Your new role

As a Senior Regulatory Affairs Associate, you will support the lifecycle management of a diverse portfolio of generic medicinal products. You will be responsible for preparing and submitting regulatory dossiers (including MAAs, variations, and renewals) in line with MHRA and EMA requirements, as well as managing post-approval activities.

You will liaise with regulatory authorities, respond to queries within agreed timelines, and ensure compliance of product labelling and documentation (SmPCs, PILs, artwork). The role also involves supporting regulatory strategy, tracking submission timelines, and monitoring evolving regulatory guidelines to assess business impact.

What you'll need to succeed

• Degree in Life Sciences, Pharmacy, or a related field
• Proven Regulatory Affairs experience within the pharmaceutical industry (generics preferred)
• Strong 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 ...