Regulatory Affairs Associate – Pharmaceutical Registration

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Lifted

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2018

🏥 Healthcare

👥 HR Tech

📋 Compliance

💰 $6.2M Series A - Lifted on 2021-06

Healthcare • HR Tech • Compliance

Lifted is a platform for health and social care providers that streamlines recruiting, onboarding, sponsorship and ongoing compliance. The product offers access to pre-screened care workers, automated background and right-to-work checks, digital training and audit-ready records, Certificate of Sponsorship and visa application support, and real-time compliance dashboards and alerts. It is built to help care employers hire, sponsor and stay audit-ready with embedded immigration and compliance workflows.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Remote Opportunity!