Regulatory Affairs Manager EU

We’re partnering with a leading pharmaceutical company that’s looking for an experienced Regulatory Affairs Manager – EU to join their UK team.

This role plays a key part in driving regulatory excellence across the EU portfolio, managing EU Marketing Authorisations, supporting post-Brexit regulatory strategy, and aligning EU and UK operations to ensure full compliance and market readiness.

You’ll lead a team of four Regulatory professionals and collaborate closely with cross-functional departments including Quality, Manufacturing, Pharmacovigilance, and Commercial. The role also supports in‑licensing, acquisitions, and new product development across EU markets.

• Lead regulatory activities for EU products within the company’s portfolio.
• Manage Marketing Authorisations (National, MRP, and DCP procedures).
• Ensure compliance with MAH responsibilities and post-Brexit regulatory requirements.
• Provide regulatory input into new product development, in‑licensing, and expansion projects.
• Oversee variations, renewals, labelling, and lifecycle management activities.
• Line manage and develop a team of 4 Regulatory Affairs professionals.
• Act as the key liaison with Competent Authorities and internal stakeholders.

• Degree in Pharmacy, Chemistry, or Life Sciences.
• Minimum 10 years’ experience in Regulatory Affairs, including strong EU expertise.
• At least 5 years’ experience managing or mentoring regulatory teams.
• Solid understanding of MAH obligations, EU submissions (MRP/DCP/National), and lifecycle management.

Mid‑Senior level

Full‑time

Quality Assurance and Project Management

Pharmaceutical Manufacturing