Rick Spring
About Rick Spring
Rick Spring is the Director of Global Regulatory Affairs Strategy at Bristol Myers Squibb, with extensive experience in regulatory affairs and a background in organic chemistry from the University of Rochester.
Title
Rick Spring is the Director of Global Regulatory Affairs Strategy at Bristol Myers Squibb based in Lawrenceville, NJ.
Previous Roles at Novo Nordisk
Rick Spring held several key positions at Novo Nordisk Inc. over a span of 16 years. From 2012 to 2018, he served as Associate Director Regulatory Affairs in Plainsboro, NJ. Prior to that, he was the Senior Manager Regulatory Affairs from 2009 to 2012, and Manager Regulatory Affairs from 2005 to 2009. He also worked as a Senior Associate, Regulatory Affairs for 11 months from 2004 to 2005, and began his tenure at the company as an Associate, Regulatory Affairs from 2002 to 2004.
Educational Background
Rick Spring studied at the University of Rochester where he earned a Master’s Degree in Organic Chemistry.
Professional Achievements
Rick Spring has contributed to significant regulatory achievements. He authored and coordinated submissions that led to the FDA granting an Orphan Drug Designation for the treatment of IPF. Additionally, he provided strategic input and led the submission process for the FDA to grant Fast Track Designation.
Leadership and Representation
In his role, Rick Spring leads a global regulatory team across multiple regions including the US, EU, Japan, China, Canada, International Operations, and CMC/Diagnostic. He serves as the regulatory representative in the Real World Evidence BMS Working Group and represents BMS on the BIO Rare Disease and Orphan Drug Committee.
Experience with International Regulatory Bodies
Rick Spring has extensive experience interacting with various international regulatory bodies. These include the EU EMA, Japan PMDA, China CDE, Korea MFDS, UK MHRA, Germany BfArM, France ANSM, Belgium FAMHP, and Brazil Anvisa.
Expertise in Biologics and Combination Products
Rick Spring is an expert in developing biologics such as insulin and PEG-FGF21, and combination products like insulin/GLP-1 receptor agonist. He has been involved in the approval of several products including TRESIBA®, RYZODEG® 70/30, SAXENDA®, and XULTOPHY® 100/3.6.
Regulatory Affairs Expertise
Rick Spring has extensive experience in various regulatory aspects involving nonclinical, clinical, CMC, device, human factors, labeling, and Real World Evidence (RWE).