Senior Regulatory Executive

CK Group
£45000 to £50000 per annum
08 Sep 2020
06 Oct 2020
Amy Lloyd
Contract Type
Full Time
CK Clinical are recruiting for a Senior Regulatory Executive to join a rapidly expanding pharmaceutical company.

This position is located in Stanmore (1 day a week working from home).

Senior Regulatory Executive Role:

- Assist in the preparation and review of dossiers for MA applications (DCP, MR or national) and ensure timely submission of applications.
- Assist in the preparation and review of dossiers for MA variation applications, MA renewals and other regulatory submissions (DCP, MR or national).
- Maintain the product life cycle and to Review of product information before product launch.
- Support the Regulatory Manager with SOPs, Change controls and review of internal processes.

Essential Requirements:

- Degree in Life Science subject with good knowledge of medicines and how they are used.
- Well-developed regulatory experience in the pharmaceutical industry.
- Understanding of the drug development process.
- Good knowledge of UK directives, ICH guidelines.
- Ability to prepare high quality regulatory dossiers.
- Experience with EU Registration and Module 3.

For more information or to apply for this Senior Regulatory Executive position, please contact CK Group, quoting job ref 48638.

It is essential that applicants hold entitlement to work in the UK.

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