Regulatory Affairs Consultant – MHRA

I have a fantastic opportunity for a Regulatory Affairs specialist contractor, to join my client on a remote, outside IR35 Fixed-term contract to manage and handle their MHRA inspection preparation, audit and then deliver a regulatory strategy following the result of the inspection.

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.
* Approval and maintenance of clinical trial applications for clinical studies for ROW and EU countries

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.