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Richard Lit


30 years Regulatory Affairs and Compliance Leader in Biotech and Pharmaceutical Industry, Richard is a former Vice President at Amgen, Inc. where he led the Global Regulatory Affairs and Safety team focused on Chemistry Manufacturing and Controls (CMC) of Amgen’s products. 

  • Expertise in Strategic life-cycle CMC development and world-wide regulatory agency interactions

  • Extensive track record in product approvals, comparability and changes to manufacturing scale and process

  • Deep knowledge and experience in protein biology, biotechnology, biologics commercialization, and regulatory affairs


Richard joined Amgen in 1994 after 4 years working at the U.S. Food and Drug Administration (USFDA).  His leadership roles in the biotechnology development and commercialization business have afforded him the opportunity to work within and alongside many business functions including: Regulatory Affairs, Clinical Development, Biologics Manufacturing, Research, Quality, Analytical Sciences, Government Affairs, Sales and Marketing, Safety, and Law.  His team spanned Amgen sites in the U.S., Canada, Australia, and the European Union.  

Richard holds a Bachelor of Science degree in Biology from UCLA and a Master of Science degree in Molecular Genetics and Microbiology from the University of California, Irvine.  He is married with two children.

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