Regulatory Affairs Manager

Regulatory Affairs Manager – Europe

We are supporting a growing pharmaceutical organisation seeking an experienced Regulatory Affairs Manager to support EU and UK regulatory activities across generic and speciality products. This is a hands‑on role requiring strong CMC expertise, end‑to‑end ownership of submissions, and the ability to operate independently while mentoring junior team members.

Key Responsibilities:

• Prepare, review, and manage Marketing Authorisation Applications (MAAs) via National, DCP, MRP, and Centralised procedures
• Lead CMC (Module 3) and Module 2 (QOS) authoring, review, and Health Authority responses
• Manage lifecycle activities, including variations, renewals, PSURs, and post‑approval commitments
• Perform dossier due diligence, gap analysis, and regulatory feasibility assessments
• Maintain and update SmPCs, PILs, labelling, and regulatory documentation
• Act as a key point of contact with MHRA, EMA, and EU competent authorities
• Support regulatory strategy development for new and in‑licensed products
• Provide regulatory input to cross‑functional teams (CMC, Quality, Supply, Clinical)
• Mentor and guide junior regulatory colleagues as required
• Maintain regulatory systems, archives, and ensure inspection readiness

Required Experience & Skills

• Degree in Life Sciences, Pharmacy, or related discipline
• 5+ years’ experience in EU/UK Regulatory Affairs within pharmaceuticals
• Strong hands‑on experience with DCP/MRP procedures
• Proven CMC authorship experience (Module 3 & QOS essential)
• Experience across generics, hybrids, and well‑established use products
• Strong understanding of EU regulatory frameworks and lifecycle management
• Ability to operate independently from day one
• Confident communicator with Health Authorities and internal stakeholders
• Experience mentoring or supporting junior team members

Desirable Experience:

• Exposure to ROW markets (e.g. Middle East, Canada, China)
• Experience with manufacturing site transfers and CMO changes
• Familiarity with regulatory databases and eCTD publishing tools

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