Regulatory Affairs Manager - EU Lifecycle Maintenance

Regulatory Affairs Manager - EU Lifecycle Maintenance

  • Location

    Berkshire, England

  • Sector:

    Regulatory Affairs

  • Job type:


  • Salary:


  • Contact:

    Matt Thomas

  • Contact email:


  • Job ref:


  • Published:

    over 1 year ago

  • Expiry date:


  • Consultant:


Job title: Regulatory Affairs Manager

A Pharmaceutical business in Berkshire are seeking a Regulatory Affairs Manager. In this role you will maintain marketing applications, develop submission strategies, and gain marketing authorisations for new countries.


  • Management of MA maintenance activities for National and MRP procedures including submission of variations and renewals
  • Liaising with affiliates to ensure submission of MAAs meets local regulatory guidelines
  • Preparation of registration dossiers and submissions of MAAs are in line with regulatory requirements
  • Act as Regulatory lead for agency interactions, including inspections, responses to agency letters and advisory meetings
  • Create and maintain SOPs and Work Instructions for the Regulatory function
  • Maintains awareness of global Regulatory legislation and assesses its impact on the business and product development programs


  • Proven experience in EU Regulatory Affairs within an established products environment
  • Upto date knowledge of applicable EU Regulations, Directives and Guidance
  • Experience working with regulatory agencies (MHRA/HPRA and EMA)
  • Medical Device experience is desirable but not essential
  • Life sciences degree or equivalent

Salary and benefits:

A competitive salary, annual bonus, car allowance and further benefits are on offer.

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk