Job Overview
- Independently manage end-to-end pharmaceutical registration activities, including regulatory strategy, dossier preparation, submission, authority correspondence, query responses, and approval timeline tracking through both national and recognition pathways.
- Review regulatory dossiers for gaps against Uzbekistan requirements; localize and prepare product information (SmPCs, package leaflets, labeling, packaging artwork, application forms, declarations, and supporting documents); and ensure consistency across Module 3, product specifications, analytical methods, and local Normative Documents.
- Prepare, review, and maintain local Normative Documents in accordance with applicable regulatory requirements, with particular attention to quality and CMC documentation.
- Coordinate translations, verification, legalization, notarization, and certification of regulatory documents; organize import permits, customs formalities, laboratory agreements, and pharmaceutical testing activities.
- Communicate with regulatory authorities, expert organizations, laboratories, and customs authorities as required; advise project stakeholders on registration requirements, compliance risks, timelines, and local regulatory trends.
- Monitor changes in Uzbekistan pharmaceutical legislation and regulatory requirements; assess impact on active projects and provide practical recommendations.
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