About
Strategic leader with more than 20 years of hands on experiences managing global regulatory teams helping companies advance product from various stages of development through to commercialization. Led numerous meeting with Global regulators including all centers of US FDA, EU, Asia Pacific countries and more.
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Work experience
- January 2019 – present
BIOTECHNOLOGY COMPANY
Sr Vice President Global Regulatory Affairs/ ClinicalLate phase biological product development towards licensure globally including BLA, MAA and market applications in other countries. - January 2009 – present
PAS Regulatory Consulting
Principal Consultant - January 2018 – January 2019
BIOTECHNOLOGY COMPANY
Vice President Global Regulatory AffairsAdvancing various phases of developmental products including cell gene therapies including CAR-T products through successful INDs/ CTAs towards licensure globally including BLA, MAA and market applications in other countries. 
January 2016 – January 2018Amgen
Director, Global Regulatory Affairs, Oncology- January 2013 – January 2015
Sysmex Inostics
Head, Global Regulatory Affairs/ Compliance - January 2010 – January 2012
Caridian BCT
Vice President, Global Regulatory Affairs 
January 2006 – January 2009Bayer HealthCare
RA Director- January 2003 – January 2006
Lung Therapeutics
Director of Regulatory Affairs - January 2001 – January 2003
SSL
VP, Regulatory Affairs - January 1998 – January 2001
Novartis
Sr. RA Mgr
