Regulatory Affairs Officer

Role & responsibilities:

• Prepare and compile CTD/eCTD dossiers for EU and MHRA submissions.
• Review and compile Modules 1, 2, and 3 (CMC documentation).
• Handle new registrations, variations, renewals, and line extensions.
• Review regulatory documents such as DMF/ASMF, CEP, Stability Data, Specifications, and Validation Reports.
• Coordinate with QA, QC, Manufacturing, R&D, and Supply Chain teams for dossier requirements.
• Prepare responses to regulatory authority queries and deficiency letters.
• Support lifecycle management activities for commercial products.
• Review packaging artworks, labels, and package inserts as per EU requirements.
• Ensure compliance with EU, MHRA, ICH, and applicable regulatory guidelines.
• Track submission timelines and maintain regulatory documentation records.