Regulatory Affairs Roles in Industry, Academia, and Consultancies
Monday, April 26th, 5:30 – 6 :30 PM CST
Contrary to popular belief, careers in regulatory affairs are not cut-and-dried administrative positions besieged with paperwork and hoops to jump through; there are nuanced grey areas and the responsibility to communicate the value of a project and comply with all regulations pertaining to that research. Regulatory affairs professionals can be found in industry, government, academia, and private practices, consulting on products and processes ranging from medical devices, pharmaceuticals, nutritional products, and in vitro diagnostics. Join our panelists to learn about what drew them to the field, the competencies that are required to be successful in these types of careers, and their advice for how to use your scientific training to support your entry into this career path.
Leslie Ann Cruz
Assoc. Director Regulatory Affairs, Natera
Leslie Cruz (’00 BS Chemistry) is originally from Chicago, IL, moved to the SF Bay Area in 2002. Leslie has a PhD in Chemistry and Chemical Biology from UCSF and completed her postdoc at Stanford. Leslie has been in Regulatory Affairs since 2013. In that time, she has worked on registrations in the US, Europe, and 30+ countries for drug/device combination products, Class II medical devices (software/hardware), and In Vitro Diagnostics. Leslie currently works for Natera, Inc., a genetic testing company focused on women’s health, transplant, and oncology products. Leslie lives in San Mateo, CA with her husband and two sons. She enjoys hiking, cooking, and watching movies with her family. Additionally, Leslie practices Aikido, a Japanese martial art, and currently holds a 2nd degree black belt.
Laura Fraczek
Senior Regulatory Affairs Specialist, Abbott Laboratories
Laura graduated from the University of Notre Dame in 2005 with a bachelor’s degree in Biological Sciences, and attended the University of Iowa to study Immunology. In the fall of 2011, she defended her PhD thesis, Complement Factor H Regulation in the Central Nervous System. She worked as a postdoctoral scholar in Dr. Rima McLeod’s laboratory at the University of Chicago for 2 years studying vaccines against Toxoplasma gondii, and joined Abbott Laboratories in 2014. There, she began as a Senior Scientist in technical support for on-market immunoassays and assisted with product launches in R&D. She joined the New Product Development team in Regulatory Affairs as a Senior Specialist in February, 2021.
Melanie Norstrom
Regulatory Affairs Manager, UChicago Medicine
Melanie completed her PhD (Biochemistry, Rock lab, 2009) and a postdoctoral position (Gardel lab) at the University of Chicago. She left bench science to pursue opportunities in clinical research. For a brief time, she was a research coordinator in Cardiology at UChicago and since 2013 has been Regulatory Affairs Manager in the Department of Medicine at UChicago.
Roger Quan
Regulatory Affairs Consultant, Regtel Consulting, LLC
Roger Quan is currently a regulatory affairs consultant. Last year, Roger left Abbott/AbbVie after a 20 year career that included stints in the R&D process chemistry, manufacturing and regulatory affairs organizations. While he was in the RA group for 14 years, Roger supported many developmental and marketed products. In the last 7 years, he managed a group of regulatory professionals that supported small molecule, biologic and device programs. Prior to Abbott, Roger received a B.S. in Chemistry from the University of Michigan and a Ph.D. in Chemistry from California Institute of Technology. After spending two years as a post-doctoral scholar at Harvard, Roger was employed at Amoco Chemical Company for three years developing polymerization catalysts.