Regulatory Affairs Associate – Pharmaceutical Registration

This is a fully remote position, open to applicants in Uzbekistan.

📋 Description

• Take charge of managing all aspects of pharmaceutical registration independently, which includes regulatory strategy, dossier preparation, submission, communication with authorities, responding to queries, and tracking approval timelines through national and recognition pathways.

• Evaluate regulatory dossiers for compliance with Uzbekistan's requirements; adapt and prepare product information (SmPCs, package leaflets, labeling, packaging artwork, application forms, declarations, and supporting documents); and ensure uniformity across Module 3, product specifications, analytical methods, and local Normative Documents.

• Develop, review, and maintain local Normative Documents in line with relevant regulatory requirements, focusing particularly on quality and CMC documentation.

• Oversee translations, verification, legalization, notarization, and certification of regulatory documents; arrange for import permits, customs processes, laboratory agreements, and pharmaceutical testing activities.

• Engage with regulatory authorities, expert organizations, laboratories, and customs authorities as necessary; provide guidance to project stakeholders regarding registration requirements, compliance risks, timelines, and current local regulatory trends.

• Stay updated on changes in Uzbekistan's pharmaceutical legislation and regulatory requirements; evaluate their impact on ongoing projects and offer practical recommendations.

⛳️ Requirements

• A university degree in Pharmacy, Pharmaceutical Sciences, Medicine, Life Sciences, or a related discipline.

• A minimum of three years of experience in pharmaceutical regulatory affairs within Uzbekistan, including overseeing local medicinal product registrations from dossier preparation to approval.

• Practical experience with both national and recognition registration pathways.

• In-depth knowledge of Uzbekistan's pharmaceutical legislation and local registration prerequisites.

• Significant experience in reviewing, localizing, and conducting gap assessments on CTD dossiers.

• Practical experience in preparing and maintaining local Normative Documents.

• Strong understanding of CMC, quality documentation, product specifications, analytical methods, and experience coordinating document legalization, sample importation, and customs processes.

• Experience collaborating with regulatory authorities, expert organizations, laboratories, and customs authorities; prior experience supporting multinational pharmaceutical companies is advantageous.

• Proficiency in written and spoken Uzbek and Russian; good working knowledge of English.

• Proven ability to independently manage multiple regulatory workstreams, demonstrating strong attention to detail, organizational skills, stakeholder management, and problem-solving abilities.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Opportunities for professional development and training.

• Flexible working hours and a supportive work environment.

• Health and wellness programs.

• Additional benefits as per company policy.