Regulatory Manager – Kazakhstan

About the role

Nazryx is looking for an experienced pharmaceutical regulatory affairs specialist based in Kazakhstan to support the market entry and registration of pharmaceutical products from international manufacturers. The specialist coordinates registration activities, assesses regulatory requirements, manages dossier preparation and submission, and ensures compliance with Kazakhstan and EAEU pharmaceutical regulations, working with manufacturers, distributors and regulatory authorities.

Key responsibilities

• Assess Kazakhstan registration requirements, including EAEU and national pathways
• Conduct regulatory gap assessments of manufacturer dossiers and identify missing documentation
• Coordinate preparation, translation, compilation and submission of registration dossiers
• Liaise with regulatory authorities and local representatives throughout the process
• Advise on GMP certification, site requirements, product documentation, labelling and packaging compliance
• Track applications, queries, approval timelines, renewals and variations
• Coordinate with manufacturers to obtain technical and regulatory documents
• Identify regulatory risks, costs and barriers to market entry
• Support regulatory planning for product portfolios in Kazakhstan and, where appropriate, other Central Asian markets
• Maintain accurate regulatory records and report progress to Nazryx

Required profile

• Degree in Pharmacy, Pharmaceutical Sciences, Chemistry or a related discipline
• Demonstrable experience in pharmaceutical regulatory affairs and medicine registration in Kazakhstan
• Practical knowledge of Kazakhstan's regulatory system and EAEU procedures
• Experience preparing or reviewing registration dossiers and coordinating submissions
• Russian-language proficiency; Kazakh and English are advantageous
• Preferred: experience with international manufacturers, generic medicines (CTD/eCTD), and existing relationships with local regulatory service providers

The engagement is part-time, consultancy or monthly-retainer, with possible expansion as the pipeline grows. Applicants should state their experience, completed projects, typical fees, timelines and availability, and send a CV and brief summary of registration experience by email.