p>Shreeya Patel at CK Clinical is recruiting a Clinical Trial Regulatory Lead to join a global pharmaceutical company at their site based in the South East on a 6 month contract.
As Clinical Trial Regulatory Lead you will be responsible for managing and assisting in all regulatory aspects for Phase 1 – Phase 4 clinical trial authorization applications conducted globally, regionally or locally, spanning all relevant Therapeutic Areas.
Main responsibilities will be:
- Attend/Lead CTA meetings to prepare/compile CTA applications for submission to global Health Authorities.
- Prepare EudraCT forms.
- Create/maintain/update CTA content plans.
- 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.
- Import documents into GRIPS/ERIS for direct filings.
- Maintain/Update CTA approval status.
- Regulatory CTA Experience is essential for this role
- Previous experience of working with pharmaceutical organisations required.
- The successful candidate will ideally be educated to degree level
The individual must be proactive and able to work independently requiring minimal supervision
For more information or to apply for the role, please contact Shreeya Patel on 01438 743047 or email firstname.lastname@example.org. Please quote reference CL25763 in
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