EU Regulatory Affairs Manager

Posted 15 hours 27 minutes ago by ABACUS MEDICINE

Permanent
Full Time
Government & Defence Jobs
Hampshire, Farnborough, United Kingdom, GU140
Job Description
The opportunity

A hands on EU Regulatory Affairs role for someone who wants more than just execution - a chance to take ownership, work broadly across regulatory and pharma projects, and help build how regulatory is done internally.

As a Deputy to the Head of Regulatory Affairs, you will work across the full regulatory lifecycle - from submissions to lifecycle management - while taking a proactive role in driving projects, improving processes, and shaping the function going forward.

Responsibilities
  • Support and execute EU regulatory activities across assigned products
  • Act as internal owner towards external regulatory partners, ensuring quality and progress
  • Work with EU procedures (centralised, DCP/MRP, national) and support submissions and lifecycle activities
  • Collaborate cross functionally with Clinical, CMC, QA, PV, and Commercial teams
  • Take initiative in projects and contribute to building and improving regulatory processes
Qualifications
  • Around 3-5 years of Regulatory Affairs experience within the EU
  • Solid knowledge of EU regulatory framework and procedures
  • A hands on and proactive mindset - you take ownership and move things forward
  • Ability to work across functions and manage multiple priorities
  • A background that shows versatility (e.g., exposure beyond a narrow RA scope or experience from different types of companies)
Benefits
  • A role with real ownership and the opportunity to grow in responsibility
  • Close collaboration with senior regulatory leadership as a trusted deputy
  • Exposure to the full regulatory lifecycle and cross functional projects
  • The opportunity to help build and shape how regulatory is handled internally
  • A dynamic environment where initiative and curiosity are valued