Dr. Hakima Ibrahim Hoseh is a regulatory affairs and due diligence consultant with extensive experience in pharmaceutical regulation, registration and assessment. She holds a Bachelor’s degree in Pharmacy from the University of Jordan and the Regulatory Affairs Certification (RAC) from the United States.
She served for 20 years as Head of the Registration Department at the Jordan Food and Drug Administration, where she chaired and participated in assessment committees covering biologicals and biosimilar, bioequivalence and renewals. Prior to that, she spent 12 years as Regulatory Affairs Associate Director and worked in regulatory affairs and due diligence at Hikma Pharmaceuticals.
Hakima has drafted and contributed to numerous regulatory guidelines covering bioequivalence, stability, CTD, biosimilar, GMP, technology transfer and value-added medicines. She is also the author of Chapter 5 of a book on post-approval changes in the MENA region, published by RAPS in 2022, and has delivered training programs on CTD/eCTD, regulatory affairs, good distribution practice, bioequivalence, biologicals and biosimilar, due diligence and good regulatory practice. She is an active RAC member and a frequent speaker at regulatory conferences and workshops.