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Regulatory Affairs Consultant

4 months ago

Greater London, United Kingdom Blackfield Associates Full time

My client, a Bio-therapeutic business based in Greater London, has defined the duties as:

- Preparation of reg affairs for MHRA inspection
- Support for ROW/EU to allow full time members of team to focus on regulatory strategy and regulatory inspection preparation.
- Part of regulatory inspection team. Responsible for implementing regulatory assigned actions as a result of the inspection
- Regulatory section of TMF/TOF and regulatory trackers for inspection checked, completed and up to date
- Project management of regulatory storyboards and processes identified by permanent members.

To be considered for this Regulatory Affairs contract, you will have:

- Extensive experience with MHRA inspections and leading inspection readiness
- Over 10 years Regulatory Affairs experience
- Clinical Trial/ Biotech knowledge
- Proven experience implanting Regulatory strategy and life cycle management
- Eu and ROW/ emerging markets regulatory knowledge

This is a remote role, fixed term (October 2023) Outside IR35.

Rates £Depending on Experience.

All applicants must hold Full Right to work status

STR Limited is acting as an Employment Business in relation to this vacancy.