Regulatory Affairs Officer - 744

ProductLife Group is looking for a RA Associate Officer

About us

Group 10


  • Preparation and submission of EU Marketing Authorisation Applications (Module 1,2,3) for Initial MAA and LCM (via DCP, MRP and NP)
  • Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
  • Ensuring compliance with all regulatory processes including MHRA and HPRA
  • Management of artwork generation
  • Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva (or comparable EDMS), DocuBridge
  • Building the submission backbone and handover to RegOps for Publishing;
  • Submit Published packed via CESP/national portal.
  • Follow-up with the authorities and close out changes (inform affiliates etc.), track approvals, update RA tools

Group 13

Required education :

  • Graduate/Master’s degree in Pharmacy

Required experience :

  •  3 to 6 yrs experience in Regulatory Affairs

Required languages :

  • English
  • German (Fluency not required)

Regulatory Affairs Officer - 744