Regulatory Affairs Manager
5 days left
- Company
- CK Clinical
- Location
- Home-Based
- Salary
- up to £55,000
- Posted
- 03 Feb 2021
- Closes
- 05 Mar 2021
- Ref
- 49757
- Contact
- Andy Leake
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- 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.
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.