Regulatory Affairs Officer - 744

Updated: March 02, 2024 04:16 PM GMT

Full-time Job in Cluj-Napoca, Cluj County

ProductLife Group

Cluj-Napoca, Romania

Regulatory Affairs Officer - 744

ProductLife Group is looking for a RA Associate Officer
About us

Group 10 Responsibilities

Responsibilities:
• 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 Profile

Required education :
• Graduate/Master’s... More Detail