Cassy Hao-ming Chang

Clinical Regulatory Affairs Manager @ BeiGene

Country

United States

City

San Rafael

Industry

Biotechnology

Skill

ELISA, Cell Culture, Biotechnology, Molecular Biology, Western Blotting, Lifesciences, PCR, Protein Purification, Biochemistry, SDS-PAGE, Microsoft Office, Gel Electrophoresis, Molecular Cloning, Transfection, Cancer, Life Sciences, Microsoft Excel, Pharmaceutical Industry, Polymerase Chain Reaction (PCR), Data Analysis

Experience

Clinical Regulatory Affairs Manager

BeiGene

2020-9 - Present · 6 yrs 1 mo

Emeryville, California, United States

Clinical Regulatory Affairs Senior Associate

BeiGene

2018-7 - 2020-9 · 2 yrs 3 mos

Emeryville, CA

International Regulatory Affairs, Sr. Associate

BioMarin Pharmaceutical Inc.

2017-9 - 2018-6 · 10 mos

International Regulatory Affairs Associate I & II

BioMarin Pharmaceutical Inc.

2016-1 - 2017-8 · 1 yr 8 mos

San Francisco Bay Area

CMC Regulatory Affairs Associate

BioMarin Pharmaceutical Inc.

2015-5 - 2015-12 · 8 mos

San Francisco Bay Area

International Regulatory Affairs Associate

Edwards Lifesciences

2014-11 - 2015-4 · 6 mos

Irvine

Led Model Change Requests for international regions intended for special access and compassionate use of the products Published Monthly International Regulatory Reports on product registration status and compliance actions Supported GUDID compliance for all class II products of a business unit

Sales and Marketing Associate

Aztec Nopal Wholesale

2014-1 - 2014-6 · 6 mos

City of Industry

Worked with cross functional group to organize various business collaboration projects, mostly B2B Participated in Healthy Beverage Expo at Long Beach to promote a company flagship product

Graduate Student Consultant

Gilead Sciences through KGI

2013-9 - 2014-5 · 9 mos

San Dimas, CA

Team Lead of Gilead Operational Excellence Team Masters Project Evaluated and streamlined the drug manufacturing process at the San Dimas plant by interviewing cross functional teams and contacting vendors of Overall Equipment Effectiveness to screen potential solutions Presented the operational efficiency process flow solution to the Gilead San Dimas Manufacturing Director and Liaison

Business Analyst Intern

Tarcine BioMed

2013-6 - 2013-9 · 4 mos

Westlake Village, CA

Utilized EvaluatePharma and BioCentury in creating databases of certain pharmaceutical drugs for strategic planning of marketing overseas Interviewed key opinion leaders for market research on the US senior care market Presented projects to overseas team in Mandarin over video conference

Research Intern

GNF

2011-1 - 2011-6 · 6 mos

La Jolla

Worked on a cancer vaccination research team and collected mice tumor development data, trending on excel graphs Prepared ELISA, tumor cell culture and maxi preps