Regulatory Affairs Manager

5 days left

up to £55,000
03 Feb 2021
05 Mar 2021
Andy Leake
Regulatory Affairs
Full Time
Contract Type
Experience Level
Experienced (non-manager)
CK Group are recruiting for a Regulatory Affairs Manager to join a global CRO company on a permanent basis. This role can be remote in the UK.

The Regulatory Affairs Manager Role:
You will be responsible for leading and coordinating regulatory submissions and perform maintenance activities.

Your responsibilities:
- Leading and coordinating regulatory submissions (CTA applications, ARSAC applications and Research Ethics Committee (REC) submissions) as part of a project team.
- Authoring and review of clinical documentation prior to submission.
- To compile and submit applications.
- To perform maintenance activities throughout the lifecycle of a clinical study.
- To act as point of contact and to communicate with Regulatory Authorities.
- Drive continuous quality improvement.

Your Background:
- Minimum of a University degree in a scientific discipline.
- Proven Regulatory experience gained within the pharmaceutical industry.
- Experience with CTA submissions is essential.
- Experience with US IND and eCTD submissions is desirable.
- Proven project leadership experience.
- Excellent attention to detail

Entitlement to work in the UK is essential. You must also be based in the UK.

Please quote reference 49757 in all correspondence.

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