Regulatory Affairs Specialist
2 weeks ago
We are seeking an experienced Regulatory Affairs Specialist to join our team as a EU Regulatory Specialist on a 12-month temporary basis.
This role will involve leading and managing the operational aspects of European regulatory filings, collaborating closely with European Regulatory groups and regional stakeholders.
About the RoleIn this position, you will oversee the preparation and submission of Marketing Authorisation Applications (MAA) and Life Cycle Management for European Centralised Procedures.
You will coordinate and communicate submission timelines, updates and regulatory changes, ensuring all stakeholders are informed.
Key Responsibilities:
- Manage the preparation and submission of MAA and Life Cycle Management for European Centralised Procedures.
- Coordinate and communicate submission timelines, updates, and regulatory changes.
- Support logistics for key meetings with the EMA and national Health Authorities.
- Author and review regulatory documents, staying current on industry guidelines and participating in global taskforces.
To be successful in this role, you will need:
- An advanced scientific background, preferably with a PhD, and 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.
The estimated salary for this position is £60,000-£80,000 per annum, depending on experience. We offer a range of benefits, including a comprehensive pension scheme and flexible working arrangements.
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