Mahaali

Regulatory Affairs

AGP Limited • Tiempo completo

Mar 2022 - Sep 2025 • 3 yrs 6 mos

CTD dossier preparation, compilation, and submission for new registrations, renewals, and variations (local and imported products) Post-registration variations (PRVs) — formulation, packaging, labeling, and manufacturer changes per DRAP guidelines Import licensing documentation, product enlistment, legalization/apostillization Artwork, labeling & packaging review for DRAP bilingual packaging, serialization, and barcoding compliance SmPC/PIL (leaflet) development in coordination with BD and Medical teams Export registration dossiers for pharma and nutraceutical products DRAP liaison — regulatory intelligence, query response, and audit/inspection support

Artwork Co-ordinator

TABROS PHARMA • Tiempo completo

Sep 2020 - Sep 2021 • 1 yr

Reviewed and approved artwork (labels, cartons, leaflets) for ongoing/existing products to ensure continued compliance with DRAP's bilingual packaging, serialization, and barcoding requirements Coordinated artwork development and approval for new product launches, working with BD and Medical teams to align packaging with regulatory and marketing requirements Managed artwork for institutional and tender packaging materials, ensuring correct specifications, labeling, and compliance for bulk/institutional supply requirements Generated and issued GTINs for new products and for tender-specific artwork Developed PILs (Patient Information Leaflets) & SmPCs (Summary of Product Characteristics) in coordination with BD & Medical for new and existing products Liaised with DRAP and internal stakeholders to resolve artwork-related queries and secure timely sign-off before print/production release

Regulatory Affairs Professional

Macter International Limited • Tiempo completo

Apr 2016 - Nov 2017 • 1 yr 7 mos

Prepared, compiled, and submitted CTD (Common Technical Document) dossiers for new drug registrations, renewals, and variations for both local and imported pharmaceutical, biological, and nutraceutical products, in accordance with DRAP requirements Ensured accuracy and completeness of dossier documentation across technical, administrative, and quality modules Coordinated with foreign principals and internal teams for the import registration of finished pharmaceutical and nutraceutical products Prepared and submitted administrative documentation for import licensing, product enlistment, and legalization/apostillization Managed post-registration variations (PRVs), including changes in formulation, packaging, labeling, and manufacturer, per DRAP guidelines Prepared and submitted renewals, supplements, clarifications, and responses to DRAP queries within regulatory timelines Reviewed and approved product artwork (labels, cartons, leaflets) for compliance with DRAP's bilingual packaging, serialization, and barcoding regulations Generated PILs and SmPCs for products in collaboration with BD and Medical teams Maintained up-to-date knowledge of DRAP regulations, policies, and notifications; liaised with DRAP officials on submissions, queries, and approvals Maintained regulatory files, approval letters, registration certificates, and tracking logs; supported internal and external audits, including DRAP inspections