Bekki is a Senior CMC Regulatory Consultant with 30 years of experience in providing strategic CMC regulatory guidance and delivery of global applications during drug development and registration across a wide variety of dosage forms, therapeutic areas and markets including direct interaction with global regulatory authorities.
The past 10 years her focus has been on CMC Regulatory Strategy, Advocacy and Intelligence driving multiple activities across complex networks. She is an industry and agency recognized expert in both ICH and emerging markets including GMP and CMC market specific requirements for global marketing applications.
Sha was co-chair of the American Association of Pharmaceutical Scientist (AAPS) CMC Focus Group for 2014-2016. Regulatory Sciences Liaison for AAPS 2015-2017.
A recognized leader and past co-chair in International Society of Pharmaceutical Engineers (ISPE) Asia Pacific and Latin America Focus Groups.