Balázs Lázár

Head of Global Regulatory CMC & Operation Department at Gedeon Richter

Speaker

Balázs Lázár graduated as a pharmacist from Semmelweis University, Budapest, in 2004. He subsequently joined Gedeon Richter Pharmaceutical Company, where he has dedicated over 20 years to regulatory affairs, obtaining broad experience and oversight.

In the first three years of his career, Balázs was responsible for regulatory activities in the United States.

After that for 12 years, Balázs served as a line manager, leading a department focused on securing new marketing authorizations within the European Union, demonstrating his strong leadership and strategic planning skills.

He then advanced to the Department Head of Global Regulatory Operations role, where he was tasked with managing various departments responsible for regulatory operations across all life cycle stages globally for three years.

Since 2022, Balázs has taken on additional responsibilities, becoming the Head of the CMC Regulatory Writing Departments while continuing in his previous role. He is the Head of Global Regulatory CMC & Operations, overseeing various departments responsible for regulatory operations across all life cycle stages globally.

In addition to his professional responsibilities, Balázs is a member of the Regulatory & Scientific Affairs Committee (RSAC) of Medicines for Europe. He is also a member of MAGYOSZ, the Hungarian Pharmaceutical Association, and HURAS, the Hungarian Regulatory Affairs Society. Furthermore, he is an invited lecturer at Semmelweis University.