Xin Chen, Ph.D.
VP, Head of Global Regulatory Affairs @ InnoCare Pharma
United States
New York City Metropolitan Area
Pharmaceuticals
Pharmaceutical Industry, Regulatory Affairs, Drug Discovery, Global Drug Development, Pharmacology, Drug Development, Medicinal Chemistry, Biomarkers, Drug Design, In Vitro, In Vivo, Oncology, Ophthalmology, Pharmacokinetics, ICH guidelines, FDA, Clinical Development, Clinical Operations, Life Sciences
Experience
VP, Head of Global Regulatory Affairs
InnoCare Pharma
New York City Metropolitan Area
Executive Director, Head US Regulatory Affairs
InnoCare Pharma
New York City Metropolitan Area
Senior Director, Head US Regulatory Affairs
InnoCare Pharma
Greater New York City Area
Global regulatory strategy development for assets of oncology and autoimmune therapeutics
Global Regulatory Affairs Leader
Sanofi
Greater New York City Area
• Regulatory strategist for programs in immunoinflammation, rare blood disease, oncology, diabetes, cardiovascular, ophthalmology therapeutic areas and modalities of small molecule, protein, antibody, gene/cell therapy and medical device • Developing and implement regulatory strategies for projects in the US, EU and ROW in various therapeutic areas • Leading Pre-IND interactions, IND filing, NDA/BLA filing, end-of-phase meetings with Agency • Managing regulatory submissions and periodic reports (DSUR, NDA/BLA Annual Report, PSUR/PBRER) • Rare disease and orphan drug product regulatory development • Gene therapy product development (viral-based and ex-vivo gene editing-based) • Breakthrough Therapy Designation • Pediatric development and requirement • Biosimilar development; interchangeability requirement • Due diligence regulatory evaluation
Principal Research Investigator and Project Leader, Discovery Research
Sanofi
Greater New York City Area
Research Scientist
Pfizer
La Jolla, CA
Senior Research Staff
Princeton University
Princeton, New Jersey, United States
Dept of Molecular Biology
Postdoctoral Fellow
National Cancer Institute (NCI)
Frederick, Maryland, United States
Education
The Ohio State University
Biochemistry
University of Science and Technology of China
Chemistry
Xin Chen, Ph.D.'s Contact Information
Phone
Find the Right Leads
Find Verified Contact Data
What LeadContact does well
Find verified emails, phone numbers, and decision-makers with 98% accuracy.
Find Leads
Find the right people by company, role, industry, location, and more.
925M+ professional profiles
Find Emails
Access verified email addresses for your target contacts.
657M+ emails
Find Phone Numbers
Get cross-validated phone data from multiple top sources.
239M+ phone numbers
More Accurate. Lower Cost.
Find contact data in 1 tool with 98% accuracy
LeadContact integrates leading enrichment tools to deliver more accurate contact data—without paying for each one.
Great conversations start with the right contact.
It’s time to find yours.