Junqi Chen
Associate Director, Global Regulatory Affairs - CMC @ Incyte
About
Experienced Senior Regulatory Manager with a demonstrated history of working in the regulatory affair. Participated in over 30 IND CMC projects for different types of drugs including small molecule, monoclonal antibody, bispecific antibody and antibody-drug conjugates (ADC). Served as project lead for 5 IND projects. Skilled in organic synthesis, chemical characterization and also familiar with programing and software includes Python, SAS, R and Microsoft Office Suite with professional formatting skills.
United States
Claymont
Management Consulting
Project Management, Regulatory Affairs, CMC, Organic Synthesis, Microsoft Office, IND, Catalyst design, Python (Programming Language), SAS, R, Inorganic Chemistry, Organometallic Chemistry, Data Analysis, Inorganic Synthesis, High-Performance Liquid Chromatography (HPLC), GC-MS, Nuclear Magnetic Resonance (NMR)
Experience
Associate Director, Global Regulatory Affairs - CMC
Incyte
Wilmington, Delaware, United States
Senior Manger, Global Regulatory Affair, CMC
Incyte
Wilmington, Delaware, United States
Senior Manager, Regulatory Affair – CMC
Aleon Pharma International, Inc.
Parsippany, New Jersey, United States
• Accomplished Module 3 documents review and preparation for multiple IND applications for different types of drugs including small molecule, monoclonal antibody, bispecific antibody and antibody-drug conjugates (ADC). • Support post-IND activities including protocol amendment review, CMC amendment preparation, DSUR review and timeline planning. • Developed automated CMC dossiers’ formatting function and conversion with Microsoft Macro.
Manager, Regulatory Affair – CMC
Aleon Pharma International, Inc.
Parsippany, New Jersey, United States
• Served as project lead for four IND projects. Main responsibilities include: o Establish timeline for pre-IND meeting and IND application. o Prepare the pre-IND meeting request, information package and participate the meeting with FDA. o Communicate and hold meetings with internal team, sponsor team and FDA to ensure the on-time submission of the IND applications. • Accomplished Module 3 dossiers review or prepared the whole Module 3 package from draft study reports in more than ten IND applications. • Developed Module 3 IND checklist for both small molecule and monoclonal antibody.
Project Manager-CMC
Aleon Pharma International, Inc.
Parsippany, New Jersey, United States
• Accomplished Module 3 documents review and preparation in multiple IND applications. • Prepared Module 3 dossiers’ template for both small molecule and monoclonal antibody. • Developed SEND dataset check sheet and validation procedure for Aleon. • Completed Module 3 dossiers’ requirements comparison between China and US IND application.
Regulatory CMC (Chemistry, Manufacturing and Controls) Intern
Aleon Pharma International, Inc.
Parsippany, New Jersey, United States
• Participate in Module 3 dossiers review for IND applications.
Education
University of Virginia
Inorganic Chemistry
Peking University
Chemistry
The Johns Hopkins University
Data Science
Junqi Chen's Contact Information
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