Local Regulatory Affairs Associate - Pharmaceutical Registration in Azerbaijan

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