Regulatory Affairs Associate - Pharmaceutical Registration

Company Description

An 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 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

Additional Information

• 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.