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.