About Shoshie Katz

Highly knowledgeable Regulatory Affairs (RA) and Quality Assurance (QA) professional with 28 years of experience working in the bio-pharmaceutical industry.

During this period, I headed the RA and QA functions in multiple companies and across several investigational drugs, biotechnology, and cell therapy products.

I led the regulatory strategy of the FDA 505(b)(2) and EMA hybrid application of a peptide product, from its discovery stage through pre-clinical and clinical stages to submission, approval, and marketing. 

I prepared and managed all types of regulatory submissions including Investigational New Drug (IND), orphan drug applications, New Drug Application (NDA) and Marketing Authorization Application (MAA), prepared briefing documents and managed full range of successful meetings with Regulatory Authorities.

I established, implemented, and maintained comprehensive QA systems throughout the product lifecycle, from discovery through the pre-clinical and clinical phases, managed successful FDA inspections and supported the product commercial launch.
Curriculum Vitae