Taisseir Kamal

Regulatory Due Diligence leadFull Time

• Job Details:‐Initiate and manage regulatory compliance and due diligence team. - Maintain oversight and ensure consistency of CTD(Common technical document)/CMC (chemistry, manufacturing and controls) documents prepared by technical parties (R&D, QA & QC), provide guidance to implementation of requirements and ensure compliance to regulatory standards. - Provide guidance, and support for the preparation of CTD responses to Health Authority (HA) inquires. - Identify needs based on Al Andalous approved plans and lead projects to : * Optimally support the CTD/CMC documentation preparation while ensuring regulatory compliance. * Manage and perform high priority regulatory projects (i.e. highly regulated accreditations, new manufacturing sites,expansions & etc.) ‐ Provide regulatory support during on-site HA inspections.

International Regulatory affairs and technical DirectorFull Time

• Job Details:Responsible of International regulatory affairs consultation. - Planning and supervising of training programs designs. - Responsible of regulatory affairs training portfolio. - Clients’ engagement for consultation and training needs analysis

Export Regulatory AffairsFull Time

• Job Details:Initiating whole system for export regulatory affairs. - Preparing for company registration in various countries. - Follow up with agents, authorities & internal departments for company &products registration requirements. - Initiate and manage the export regulatory affairs team. - Market access and new agents. - Contracts preparation. - Follow up with agents for sales forecast and orders follow-up. - Arrange for audits. Achievements: - List of 30 CTDs. 14 products in NMPB of Sudan. 2 products in Azerbaijan. One product in Georgia. - Submission of 54 dossiers for registration in various regulatory authorities (SFDA, Romania/EMA, Sudan, Azerbaijan, Georgia, Uzbekistan, Yemen, Ethiopia, Uganda, Kazakhstan, Moldova, UAE,Iraq, Palestine).