Mesfin is a seasoned regulatory affairs professional with an extensive career spanning over 18 years in the clinical research sector. His invaluable expertise has facilitated multinational, global clinical trials throughout all phases of development and across diverse therapeutic domains. His profound knowledge is particularly notable in oncology and rare diseases, and he has played a pivotal role in advancing regulatory activities across various regions, including the EU, the Americas, Asia Pacific, North Africa, and the Middle East.
His rich experience encompasses a broad spectrum, ranging from pharmaceuticals to small and large molecules, GMO-based vaccines, and Gene Therapy products. He is well-versed in the meticulous compilation, review, and collation of regulatory dossiers and adept at forging meaningful connections with regulatory authorities and external vendors. Mesfin’s collaborative spirit and keen insight extend to his pivotal role in supporting clinical development activities, providing invaluable regulatory strategy and guidance to cross-functional teams and sponsors across various product types and therapeutic areas.
