LOCAL REGULATORY AFFAIRS ASSOCIATE - PHARMACEUTICAL REGISTRATION IN AZERBAIJAN

<p>For this project, the selected candidate will:</p><ul><li>Develop and execute local regulatory strategies for medicinal product registrations.</li><li>Manage registration activities from dossier preparation and submission through approval.</li><li>Review regulatory dossiers and conduct gap assessments against Azerbaijan’s local requirements.</li><li>Review, adapt, and localize CTD documentation, including CMC and quality-related materials.</li><li>Prepare and localize product information, including SmPCs, package leaflets, labeling, and packaging artwork.</li><li>Prepare administrative documents such as application forms, cover letters, declarations, and supporting documentation.</li><li>Coordinate translations, document verification, legalization, notarization, and certification.</li><li>Communicate with regulatory authorities, expert organizations, laboratories, and customs authorities.</li><li>Prepare responses to authority questions and monitor submission review timelines.</li><li>Coordinate import permits, customs formalities, laboratory agreements, sample shipments, and pharmaceutical testing.</li><li>Obtain consultations from regulatory authorities or expert organizations when needed.</li><li>Monitor changes to Azerbaijan’s pharmaceutical legislation and assess their impact on active or planned submissions.</li><li>Advise project stakeholders on registration requirements, regulatory trends, timelines, and compliance risks.</li><li>Manage multiple regulatory projects while maintaining accurate, complete, and submission-ready documentation.</li></ul> <p>&#xa0;</p><ul><li>A university degree in Pharmacy, Pharmaceutical Sciences, Medicine, Life Sciences, or a related discipline.</li><li>At least three years of pharmaceutical regulatory affairs experience in Azerbaijan.</li><li>Demonstrated experience managing local medicinal product registrations and post-approval lifecycle activities.</li><li>Hands-on experience managing registration procedures from dossier preparation through final approval.</li><li>Strong knowledge of Azerbaijan’s pharmaceutical legislation, registration requirements, and regulatory practices.</li><li>Extensive experience reviewing and localizing CTD dossiers.</li><li>Strong knowledge of CMC and quality documentation, including product specifications and local compliance requirements.</li><li>Experience coordinating document legalization, sample importation, customs processes, and laboratory testing.</li><li>Established experience working with health authorities, expert organizations, laboratories, and customs authorities.</li><li>Experience supporting multinational pharmaceutical companies or international project teams.</li><li>Fluent written and spoken Azerbaijani and Russian.</li><li>Strong working English skills for reviewing documentation and communicating with regional and global stakeholders.</li><li>Excellent analytical, organizational, communication, and stakeholder-management skills.</li><li>Strong attention to detail, ownership, accountability, and the ability to work independently.</li><li>A proactive, solution-oriented approach to regulatory challenges and competing timelines.</li></ul> <p>Remote Opportunity!</p><p>Work in Azerbaijan Business Hours</p>