EU Regulatory Affairs Professional
1 week ago
Park Street People Ltd is currently seeking a highly skilled EU Regulatory Affairs Specialist to join their team based in the outskirts of London on a full-time, 12-month temporary basis (35 hours per week).
This role involves leading and managing the operational aspects of European regulatory filings, collaborating closely with European Regulatory groups and various regional and global stakeholders.
- Key Responsibilities:
- Oversee the preparation and filing of Marketing Authorisation Applications (MAA) and Life Cycle Management for European Centralised Procedures, ensuring smooth regulatory submissions.
- 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.
Estimated Salary: £60,000 - £80,000 per annum, depending on experience.
RequirementsWe are looking for an advanced scientific background (PhD preferred) with strong experience in European regulatory procedures. Proven project leadership skills, expertise in handling MAA processes, and supporting strategic initiatives are also essential.
The ideal 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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