Science, Pharmaceutical & Food

Reg Affairs Specialist – Labelling –

  • Contract
  • Remote
  • Greater London
  • 41888098

PE Global is currently recruiting for a Reg Affairs Specialist for a 6-month contract role with a leading multinational Biopharma client based in London.

Job Responsibilities

  • Prepare and submit high quality regulatory filings for the UK affiliate to the MHRA.
  • Support and action the regulatory end-to-end process to execute company and Brexit related activities.
  • Maintain marketing authorisations (MAs) approved via National, Mutual Recognition/Decentralised and Centralised procedures.
  • Generate and maintain prescribing information, patient information leaflets and packaging components, including artwork implementation and management
  • Provide regulatory input to business stakeholders on potential product issues and deletions/divestitures for the respective product portfolio.
  • Implement and communicate changes to relevant stakeholders, and ensure all compliance activities and company systems are correctly managed.

Requirements

  • Degree or higher (or equivalent qualifications/experience) in pharmacy or a life-science subject.
  • 5+ years of working in a regulatory affairs role in the pharmaceutical industry is necessary with in-depth knowledge of EU/UK regulatory procedures and a comprehension of EU and UK Medicines Legislation.
  • Experience of working in UK affiliate regulatory role, with preparation and submission of applications to and working with the MHRA.
  • Experience of working within electronic regulatory tracking databases and document/artwork management systems.

Interested candidates should submit an updated CV.
Please click the link below to apply, call Veronica on +44 203 868 9000 or alternatively send an up to date CV to veronica.perez@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

By continuing to use the site, you agree to the use of cookies. More Information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close