Our client, a global pharmaceutical company, is currently looking for a Regulatory Affairs Strategist to join their team based on the outskirts of London on a full-time, 12-month temporary basis (35 hours per week).
In this role, you’ll lead and manage the operational aspects of European regulatory filings, collaborating closely with European Regulatory groups and a range of regional and global stakeholders.
Key Responsibilities
Oversee the preparation and filling 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.
Requirements
Strong experience in European regulatory procedures.
Proven project leadership skills, with expertise in handling MAA processes and supporting strategic initiatives.
Strong communication and collaboration skills, with a deep understanding of EU regulatory requirements and the ability to connect effectively across teams.
Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed, or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.
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