Regulatory Affairs Associate - Pharmaceutical Registration

 

• 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.

 

• 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
• This 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.