- 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.