Regulatory Affairs Associate - Pharmaceutical Registration

Google Chrome Microsoft Edge Apple Safari Mozilla Firefox Regulatory Affairs Associate - Pharmaceutical RegistrationContractCompany DescriptionAn enterprise client is seeking an experienced Local Regulatory Affairs Associate to provide regulatory support for pharmaceutical products in Uzbekistan. The candidate will independently manage medicinal product registration and lifecycle maintenance activities, including dossier review and localization, health authority interactions, quality documentation, sample testing coordination, and regulatory intelligence.Job Description 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.Qualifications University degree in Pharmacy, Pharmaceutical Sciences, Medicine, Life Sciences, or a related fieldAt least three years of pharmaceutical regulatory affairs experience in Uzbekistan, including managing local medicinal product registrations from dossier preparation through approvalHands-on experience with both national and recognition registration pathwaysStrong knowledge of Uzbekistan pharmaceutical legislation and local registration requirementsExtensive experience reviewing, localizing, and performing gap assessments on CTD dossiersPractical experience preparing and maintaining local Normative DocumentsStrong knowledge of CMC, quality documentation, product specifications, analytical methods, and experience coordinating document legalization, sample importation, and customs proceduresExperience working with regulatory authorities, expert organizations, laboratories, and customs authorities; previous experience supporting multinational pharmaceutical companies is preferredFluency in written and spoken Uzbek and Russian; good working proficiency in EnglishDemonstrated ability to independently manage multiple regulatory workstreams, with strong attention to detail, organization, stakeholder management, and problem-solving skillsAdditional InformationThis is a project-based consulting engagement supporting pharmaceutical registration and lifecycle activities in Uzbekistan.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.By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy applyI'm interestedI'm interestedPrivacy NoticeI'm interestedRefer a friendshare this jobShare to WeChat×Copy the link and open WeChat to share.Copy to clipboardOpen WeChatShare to WeChat×Use Scan QR Code in WeChat and click ··· to...