Local Regulatory Affairs Associate - Pharmaceutical Registration in Azerbaijan

Upwork

Yerləşmə
Bakı
Təcrübə
3+ il
Məşğulluq
Tam ştat
Əməkhaqqı
Göstərilməyib
Yerləşdirilib
23 iyul 2026
Dillər
Azerbaijani, Russian, English

Bacarıqlar və texnologiyalar

Vakansiya haqqında

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.

Job Description

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.

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.

Additional Information

Remote Opportunity!

Work in Azerbaijan Business Hours

Şirkət haqqında

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Local Regulatory Affairs Associate - Pharmaceutical Registration in Azerbaijan
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