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.
Key Responsibilities
* 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.
Requirements
* 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.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Quality Assurance and Project Management
Industries
Pharmaceutical Manufacturing
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