Regulatory Affairs Associate - Steriles - EU Generic

Regulatory Affairs Associate - Steriles - EU Generic

  • Location

    Essex, England

  • Sector:

    Regulatory Affairs

  • Job type:


  • Salary:


  • Contact:

    Matt Thomas

  • Contact email:


  • Job ref:


  • Published:

    about 1 year ago

  • Expiry date:


  • Consultant:


Job title: Regulatory Affairs Associate - Steriles - European Generic Registration

A global pharmaceutical company in Essex are seeking an experienced regulatory affairs individual to join their EU submissions team. This role will focus on Steriles within the European markets.


  • Manage new MAAs submitted via Decentralised (DCP), Mutual Recognition (MRP) and Centralised (CP) procedures.
  • Work closely with line manager to coordinate preparation of high-quality dossiers, which fulfil regulatory requirements and Health Authority (HA) expectations.
  • Where requested, review third party dossiers and with line manager identify risks and communicate RA input on approvability to other team members.
  • Keep up to date on regulatory trends in the EU Region.
  • Provide central RA support to EU countries, CA, CH and International Markets.


  • Pharmacy/Chemistry or Life Sciences degree.
  • Knowledge of regulatory requirements, process, procedures, & pathways.
  • Experience in Sterile/Complex Generics is essential
  • Prior EU Regulatory experience would be advantageous

Salary and benefits:

A competitive annual salary and benefits scheme is on offer with this role

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