Regulatory Affairs Consultant - Greater London, United Kingdom - Blackfield Associates

Blackfield Associates
Blackfield Associates
Verified Company
Greater London, United Kingdom

1 week ago

Tom O´Connor

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Tom O´Connor

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Description
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.
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