Senior Regulatory Executive
CK Clinical are recruiting for a Senior Regulatory Executive to join a rapidly expanding pharmaceutical company.
Location: This position is located in Stanmore (1 day a week working from home).
Senior Regulatory Executive Role:
- Assist inthe 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.
Apply: For more information or to apply for this Senior Regulatory Executive position, please contact Amy Lloyd on 01438 842979 or email email@example.com, quoting job ref 48638.
It is essential that applicants hold entitlement to work in the UK.