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Regulatory Affairs Consultant

3 months ago

Portsmouth, United Kingdom Blackfield Associates Full time

Our client, an independent pharmaceutical company who specialise in the development and manufacture of specialist medicine and generics, have an opportunity for a European experience Regulatory Lead to join their team in Hampshire on a 12-month FTC.



If your skills, experience, and qualifications match those in this job overview, do not delay your application.

As Regulatory Affairs Consultant, you will have the below responsibilities:

  • You will perform the necessary regulatory tasks with data and documentation review, submission execution - to obtain new Marketing Authorisations in UK (GB/NI) for both generic and innovative products.
  • Ensure technical dossiers are aligned and optimised with EU Regulatory data requirements for new EU Marketing Authorisation Applications and post approval variations, where required
  • Perform the necessary regulatory activities for your assigned projects from pre-submission until post-approval handover to regulatory maintenance teams. This includes review and optimisation of dossier content (particularly Module 3), compilation and submission of files, resolution of Health Authority questions in cooperation with other functions, and submission of variations where required
  • Lifecycle management activities across the group’s portfolio
  • Communicate regulatory information for assigned projects before, during and after approval and provide regulatory support to project teams, stakeholders, and customers, as required
  • Track and monitor queries/deficiency letters/commitments from/to European Health Authorities to ensure these are implemented and conformed in compliance with.


To be considered for the Regulatory Affairs Consultant FTC, you will have the following:


  • Educated to degree level in relevant life science disciplines
  • Minimum 3 years Regulatory Affairs experience ideally with medicines, medical devices, OTCs
  • Must have lead Lifecycle Management tasks, including Pre-approval, Post-approval, and Variations


This is an FTC, Hybrid working from our clients Hampshire office. Salary DOE