EU Clinical Regulatory Affairs Specialist UK
Permanent / UK
Clinical Regulatory Affairs Specialist - Berkshire
Due to expansion, a fantastic opportunity has arisen for a Regulatory Affairs Specialist, with a leading CRO. This is a permanent position, office-based in Hertfordshire. The role will be involved within the clinical team dealing with Regulatory affairs requirements for Clinical Trials.
- Ensure clinical trial applications are filed to target and amended appropriately
- Assure appropriate standards and policies are maintained for all technical aspects of the company's regulatory activities
- Ensures clinical trials are conducted such that subjects' rights, safety and well being are protected and that the clinical trial data are reliable.
- Provide regulatory input to stock and supply issues
- Providing regulatory support and advice with all projects
- Develop professional working relationships with assessors and administrative staff within the regulatory agencies
- Mentoring of Junior members of staff
- Educated to degree-level in a life science discipline
- Advanced understanding of ICH-GCP
- Strong Clinical Trial Knowledge
- Excellent written and spoken English
- Eligible to work in the UK
Key words Regulatory affairs, CRO, Clinical Research, FDA, EMA, MHRA, EMEA, Director, Global, London, Office based
If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email
We regard all communication and correspondence as confidential. Full job descriptions are available on request.