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.
Do you have the right skills and experience for this role Read on to find out, and make your application.
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, xwzovoh 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