Role & responsibilities:
Prepare and compile CTD/eCTD dossiers for EU and MHRA submissions.
Review and compile Modules 1, 2, and 3 (CMC documentation).
Handle current 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.