Kevin Swiss

Kevin Swiss has a diverse work experience spanning over 25 years in the pharmaceutical industry. Kevin held the role of Vice President at Syner-G BioPharma Group since 2020, providing consultation to pharmaceutical companies on CMC regulatory issues. Prior to that, they were the Principle at CMC GMP LLC since 2013.

From 2013 to 2014, Kevin worked as the Senior Director Tech Ops at Nautilus Neurosciences, Inc., where they led all CMC, CMC-regulatory, and QA for an approved drug, Cambia. Kevin successfully resolved key issues and ensured FDA compliance.

Before that, Kevin served as the Regulatory Affairs Principal at BIOTRONIK from 2012 to 2013, where they assisted in resolving deficiency comments in IDE submissions and established strategies for FDA approvals.

From 2008 to 2012, Kevin held the position of Director CMC Regulatory at Kowa Research Institute, Inc., where they were responsible for the strategy and FDA approval of LIVALO NDA in the first cycle review.

Kevin also worked as the Director Tech Ops at Proethic Pharmaceuticals from 2006 to 2008 and as the Director Regulatory Consulting at PharmaNet from 2003 to 2006.

Kevin'searlier experience includes roles such as Senior Manager CMC Regulatory at Inex Pharmaceuticals, Chemist GS-1320 CMC drug reviewer at FDA, and Postdoc Medicinal Chemist at Boehringer Ingelheim Pharmaceuticals.

Kevin Swiss has extensive knowledge and expertise in CMC, CMC regulatory, and QA. Kevin has a proven track record of successfully resolving issues, ensuring FDA compliance, and leading strategic initiatives for drug approvals.

Kevin Swiss obtained a Bachelor of Science (BS) degree in Chemistry from the University of North Carolina at Greensboro from 1982 to 1985. Kevin then pursued a Master of Arts (MA) degree in Chemistry at Princeton University from 1985 to 1987. From 1987 to 1991, Kevin completed their education by obtaining a Ph.D. in Organic Chemistry from Emory University.