Senior Regulatory Affairs Associate, EU & UK Market

About the role

We are looking for a Senior Regulatory Affairs Associate to join an established, research‑driven generics pharmaceutical company operating across the UK and EU. In this role you will manage the regulatory lifecycle of a diverse portfolio of generic medicines, ensuring compliance with both MHRA and EMA requirements.

Key responsibilities

• Prepare and submit regulatory dossiers, including MAAs, variations and renewals, using CTD/eCTD formats.
• Manage post‑approval activities such as labeling updates, SmPCs, PILs and artwork compliance.
• Liaise with MHRA and EMA authorities, responding to queries within agreed timelines.
• Support regulatory strategy, track submission timelines and monitor evolving regulatory guidelines.
• Ensure product documentation meets UK and EU regulatory standards.

Required profile

• Degree in Life Sciences, Pharmacy or a related discipline.
• Proven experience in regulatory affairs within the pharmaceutical industry, preferably generics.
• Strong knowledge of UK (MHRA) and EU (EMA) regulatory frameworks.
• Experience with CTD/eCTD submissions and lifecycle management.
• Familiarity with variations and post‑approval processes.
• Excellent organisational and communication abilities.

Required skills

• CTD/eCTD dossier preparation
• Regulatory submission management (MAA, variation, renewal)
• UK MHRA and EU EMA regulatory knowledge
• Lifecycle management of generic products
• Labeling compliance (SmPC, PIL, artwork)

What we offer

• Hybrid working model – 3 days onsite in London, 2 days remote.
• Collaborative, team‑oriented environment.
• Exposure to a broad generics portfolio across UK and EU markets.
• Career development and ongoing training opportunities.