Regulatory Affairs Associate – Pharmaceutical Registration

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Lifted

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2018

🏥 Healthcare

👥 HR Tech

📋 Compliance

💰 $6.2M Series A - Lifted on 2021-06

Healthcare • HR Tech • Compliance

Lifted is a platform for health and social care providers that streamlines recruiting, onboarding, sponsorship and ongoing compliance. The product offers access to pre-screened care workers, automated background and right-to-work checks, digital training and audit-ready records, Certificate of Sponsorship and visa application support, and real-time compliance dashboards and alerts. It is built to help care employers hire, sponsor and stay audit-ready with embedded immigration and compliance workflows.

📋 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.

🎯 Requirements

• University degree in Pharmacy, Pharmaceutical Sciences, Medicine, Life Sciences, or a related field • At least three years of pharmaceutical regulatory affairs experience in Uzbekistan, including managing local medicinal product registrations from dossier preparation through approval • Hands-on experience with both national and recognition registration pathways • Strong knowledge of Uzbekistan pharmaceutical legislation and local registration requirements • Extensive experience reviewing, localizing, and performing gap assessments on CTD dossiers • Practical experience preparing and maintaining local Normative Documents • Strong knowledge of CMC, quality documentation, product specifications, analytical methods, and experience coordinating document legalization, sample importation, and customs procedures • Experience working with regulatory authorities, expert organizations, laboratories, and customs authorities; previous experience supporting multinational pharmaceutical companies is preferred • Fluency in written and spoken Uzbek and Russian; good working proficiency in English • Demonstrated ability to independently manage multiple regulatory workstreams, with strong attention to detail, organization, stakeholder management, and problem-solving skills.