Nan Chen, PhD, RAC
Senior Manager Regulatory Affairs @ Amgen
About
Regulatory professional with pharmaceutical experience in the areas of Regulatory Affairs and analytical chemistry. Proven ability to successfully prepare and submit regulatory filings (dossiers). Good working experience in generic drug products and Regulatory Affairs processes for lifecycle management. Sound knowledge of the Code of Federal Regulations and FDA/ICH Guidelines. Strong content knowledge of US submissions. Broad CMC experience with drug substance, drug product, manufacturing processes and validation, analytical methods, and stability regulatory requirements. Regulatory Affairs Certified: RAC - US, Dec 2017.
United States
Thousand Oaks
Pharmaceuticals
Regulatory Affairs, Change Control, GMP, Formulation, HPLC, Pharmaceutics, Analytical Chemistry, Characterization, Chromatography, Pharmaceutical Industry, Life Sciences, Research and Development (R&D), Drug Development, Technology Transfer, U.S. Food and Drug Administration (FDA), Biotechnology, Regulatory Submissions, Drug Delivery, Particle Size Analysis, FTIR
Experience
Senior Manager Regulatory Affairs
Amgen
Thousand Oaks, California, United States
Regulatory Affairs Manager
Amgen
Thousand Oaks, CA
Senior Regulatory Affairs Associate
Amgen
Thousand Oaks, California, United States
Senior Regulatory Affairs Associate
Pfizer
Lake Forest
Associate Research Scientist
Pfizer
Lake Forest
Interim Group Leader
Pfizer
Lake Forest
Scientist
Hospira
Lake Forest, IL
Research Assistant
University of Iowa
Iowa City, Iowa Area
Summer Intern
Eli Lilly and Company
Indianapolis, Indiana Area
Conducted in a project to study the application of laser diffraction particle size analysis technique to formulation development and characterization of large molecule drug dispersion, which helps understanding the application of particle sizee data to formulation screening and the relationship to dispersion settling rates and dose uniformity from multiple dose containers.
Summer Intern
Novartis
Lincoln, Nebraska Area
Participated in a research project to improve the solubility of drug compounds using cosolvent systems for transdermal application; designed experiments; selected safe solvents and materials as excipients; compared formulations under various stability conditions using HPLC
Education
University of Iowa
Pharmaceutical Science
University of Iowa
Chemistry
University of Science and Technology of China
Material Science and Engineering
University of Science and Technology of China
Business Administration
The High School Affiliated to Renmin University of China
Nan Chen, PhD, RAC's Contact Information
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