Senior VP of Regulatory Affairs / Clinical
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.
2019 - Present
Sr Vice President Global Regulatory Affairs/ Clinical
Late phase biological product development towards licensure globally including BLA, MAA and market applications in other countries.
2009 - Present
PAS Regulatory Consulting
2018 - 2019
Vice President Global Regulatory Affairs
Advancing 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.
2016 - 2018
Director, Global Regulatory Affairs, Oncology
2013 - 2015
Head, Global Regulatory Affairs/ Compliance
2010 - 2012
Vice President, Global Regulatory Affairs
2006 - 2009
2003 - 2006
Director of Regulatory Affairs
2001 - 2003
VP, Regulatory Affairs
1998 - 2001
Sr. RA Mgr