Regulatory CTA Consultant

Description

Role: Regulatory CTA Consultant
Duration: 6 months
Location: Buckinghamshire
Rate: Depending on experience

The purpose of the role will be to manage and assist in all regulatory aspects for Phase 1 - Phase 4 clinical trial authorization applications conducted globally, regionally or locally, spanning all Therapeutic Areas .

Ideally the suitable candidate will be able to commence work in early January with interviews being conducted of the next week.

The candidates main responsibilities will involve:

- Attending CTA WG meetings to prepare/compile CTA applications for submission to global Health Authorities

- Prepare EudraCT forms

- Create/maintain/update CTA content plans. Ensure review with country LTMs

- Assist/Prepare minutes of the CTA WG meetings

- Prepare the list of ongoing trials using available template

- Follow-up with Core document owners on status of documents needed for the CTA packages

- Interface with publishing/production on publishing/dispatch/submission of CTAs from CTA content plans

- Maintain/Update CTA approval status.

If this role is of interest to you then please contact Peter Duvall on

To find out more about Real please visit www.realstaffing.com