Job Opportunities API

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