J
Joy Ning

Senior VP of Regulatory Affairs / Clinical

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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.

Work experience

2019 - Present

BIOTECHNOLOGY COMPANY

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

Principal Consultant

2018 - 2019

BIOTECHNOLOGY COMPANY

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.

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2016 - 2018

Amgen

Director, Global Regulatory Affairs, Oncology

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2013 - 2015

Sysmex Inostics

Head, Global Regulatory Affairs/ Compliance

2010 - 2012

Caridian BCT

Vice President, Global Regulatory Affairs

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2006 - 2009

Bayer HealthCare

RA Director

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2003 - 2006

Lung Therapeutics

Director of Regulatory Affairs

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2001 - 2003

SSL

VP, Regulatory Affairs

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1998 - 2001

Novartis

Sr. RA Mgr

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