Regulatory CTA Specialist
Andy Leake at CK Clinical is recruiting for a Regulatory CTA Specialist to join a leading innovative pharmaceutical company at their site based in Hertfordshire. This is initially on a 6 month contract basis.
Your main duties will be to:
- Be responsible for the regulatory management of UK CTAs for assigned products through national and VHP procedures.
- Act as subject matter expert (SME) for the department in clinical trial related subject or process areas.
- Contribute to efficiency and process improvement including development of best practices, SOP maintenance and appropriate tracking tools, templates.
Further responsibilities will include:
- Maintaining awareness of and compliance to laws and regulations applicable.
- Ensuring high quality regulatory submissions are prepared and submitted in a timely manner.
- Providing guidance on relevant regulatory issues to support internal customers.
The ideal candidate for this role will have:
- A university degree in a scientific field.
- Proven experience in Regulatory Affairs, with working knowledge of EU/UK CTA management and GCP.
- The ability to plan and manage multiple CTA submissions and amendments.
- Good communication skills, teamwork, IT skills (MS Office, TrackWise).
For more information or to apply for this position, please contact Andy Leake on 01438 842 966 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46343 in all correspondence.