Local Regulatory Affairs Associate - Pharmaceutical Registration in Azerbaijan
Remote
Job Summary
Develop and execute local regulatory strategies for medicinal product registrations in Azerbaijan, managing end-to-end activities from dossier review and localization through submission and approval. Review regulatory dossiers, conduct gap assessments, and adapt CTD documentation including CTD, CMC, and quality materials. Prepare product information such as SmPCs, package leaflets, and labeling, while coordinating translations, document verification, and customs formalities. Communicate with regulatory authorities, laboratories, and customs agencies, preparing responses to authority questions and monitoring submission timelines. Monitor changes to pharmaceutical legislation and advise stakeholders on compliance risks and timelines. Requires three years of pharmaceutical regulatory experience in Azerbaijan, fluency in Azerbaijani and Russian, and strong English skills. Remote work within Azerbaijan business hours.
Required Qualifications
- 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
- Work in Azerbaijan Business Hours
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