At Health Options Europe Ltd, I author, compile and publish eCTD submissions while coordinating 12 client products from brief to first commercial batch. I align formulation, specifications and manufacturing records with regulatory files and support UK manufacturing inspection readiness.
At Darou Pakhsh Pharmaceutical Co., I oversaw around 140 marketing authorisation applications, 90 post-approval variations and 80 renewals, with around 99% on-time delivery. I also led regulatory and technical transfers, including meropenem vials, omeprazole capsules and enoxaparin pens.
At Iran Food and Drug Administration, I assessed biological and vaccine dossiers, conducted GMP inspections and contributed to national vaccine regulation. My work also includes veterinary product registrations, regulatory systems, and teaching pharmaceutical manufacturing, regulatory affairs and GMP.
