Dr. Hagit Hoch-Marchaim has 16 years of experience in the Biotech industry, 12 years of which in Regulatory Affairs positions (her other roles were in R&D and pre-clinical development). Hagit has gained significant knowledge and experience in all aspects of drug development throughput the product life cycle. She started her career in Regulatory Affairs in Makhteshim – Agan Industries, and continued in Kamada Ltd. as RA product manager and pre-clinical development manager, in Omrix Biopharmaceuticals Ltd. (a J&J company) as the RA Dept. manager, in CureTech Ltd. as the VP RA and in Alcobra Ltd. as the Senior VP RA.
Hagit holds a Ph.D. in Biology from the Hebrew University of Jerusalem and has done her post-doctoral studies in the Weizmann Institute of Science. She has completed her MBA studies in Biomedical Management (summa cum laude) in The College of Management, Israel.
At Omrix Biopharmaceuticals Ltd. Hagit served as the RA Department Manager, where she has managed 13 RA employees and was responsible for many successful regulatory submissions (both pre- and post- marketing authorization) worldwide (including FDA, EMA, IMOH, Canada, Asia Pacific and Latin America). Hagit attended many regulatory meetings, with the FDA, IMOH, EMA, PEI and Health Canada. In addition, she participated in FDA and IMOH plant inspections and was involved in other QA related activities including being a member in the Quality System Improvement Plan team organized by Ethicon. At CureTech Ltd. and Alcobra Ltd., her responsibilities as VP RA include preparation and management of FDA as well as EU, IMOH and ROW submissions, review of clinical documents, management of FDA meetings and advising on compliance issues.
Currently, Hagit shares her experience with companies as an independent consultant providing regulatory consultation services to companies, bio-med incubators and VCs, either on a permanent basis leading the Company’s Regulatory Affairs activities or on specific projects. Her consultation spans the whole spectrum of regulatory strategy, GAP analysis, regulatory submissions, preparation and management of meetings with Health Authorities, quality agreements, non-clinical studies, inputs on GMP manufacturing process for biologics, data and marketing exclusivity, stability studies and many more.
Hagit is specialized in biological products, combination products and pharmaceuticals but has experience with other types of products as well.