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