REGULATORY AFFAIRS ASSOCIATE - PHARMACEUTICAL REGISTRATION

<p>&#xa0;</p><ul><li>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.</li><li>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.</li><li>Prepare, review, and maintain local Normative Documents in accordance with applicable regulatory requirements, with particular attention to quality and CMC documentation.</li><li>Coordinate translations, verification, legalization, notarization, and certification of regulatory documents; organize import permits, customs formalities, laboratory agreements, and pharmaceutical testing activities.</li><li>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.</li><li>Monitor changes in Uzbekistan pharmaceutical legislation and regulatory requirements; assess impact on active projects and provide practical recommendations.</li></ul> <p>&#xa0;</p><ul><li>University degree in Pharmacy, Pharmaceutical Sciences, Medicine, Life Sciences, or a related field</li><li>At least three years of pharmaceutical regulatory affairs experience in Uzbekistan, including managing local medicinal product registrations from dossier preparation through approval</li><li>Hands-on experience with both national and recognition registration pathways</li><li>Strong knowledge of Uzbekistan pharmaceutical legislation and local registration requirements</li><li>Extensive experience reviewing, localizing, and performing gap assessments on CTD dossiers</li><li>Practical experience preparing and maintaining local Normative Documents</li><li>Strong knowledge of CMC, quality documentation, product specifications, analytical methods, and experience coordinating document legalization, sample importation, and customs procedures</li><li>Experience working with regulatory authorities, expert organizations, laboratories, and customs authorities; previous experience supporting multinational pharmaceutical companies is preferred</li><li>Fluency in written and spoken Uzbek and Russian; good working proficiency in English</li><li>Demonstrated ability to independently manage multiple regulatory workstreams, with strong attention to detail, organization, stakeholder management, and problem-solving skills</li></ul> <ul><li>This is a project-based consulting engagement supporting pharmaceutical registration and lifecycle activities in Uzbekistan.</li><li>Candidates should be available to work independently, coordinate with local and international stakeholders, and provide timely updates on submissions, authority feedback, risks, and upcoming milestones.</li></ul>