Regulatory Specialist in European Affairs
3 weeks ago
We are recruiting an experienced EU Regulatory Affairs Specialist to work closely with our client's European Regulatory group and regional/global stakeholders.
This position involves overseeing the preparation and filing of Marketing Authorisation Applications (MAA) and Life Cycle Management for European Centralised Procedures, ensuring smooth regulatory submissions.
- Key Responsibilities:
- Coordinate and communicate submission timelines, updates, and regulatory changes, keeping all stakeholders well-informed.
- Support logistics for key meetings with the EMA and national Health Authorities, collaborating closely with cross-functional teams to drive strategy.
- Author and review regulatory documents, staying current on industry guidelines and participating in global taskforces.
Salary: Estimated £65,000 - £85,000 per annum, depending on experience.
QualificationsA PhD in a relevant field and significant experience in European regulatory procedures are required. Proven project leadership skills, expertise in handling MAA processes, and supporting strategic initiatives are also essential.
The successful candidate will possess strong communication and collaboration skills, a deep understanding of EU regulatory requirements, and the ability to connect effectively across teams.
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