Steve Madden

Steve Madden is a Regulatory Affairs and Quality Assurance professional with a diversified background accumulated from more than 20 years of experience.

He successfully planned and prepared regulatory submissions, including INDs, European and Canadian CTAs, SME applications, BTD requests and Orphan Drug applications. He's also coordinated and prepared teams for pre-IND, EOP1 and EOP2 regulatory agency (FDA and EMA) meetings. Acted as primary liaison with regulatory authorities (FDA and EMA) to facilitate review of regulatory submissions.

Most recently, Steve was Vice President, Regulatory Affairs and Quality Assurance, at NiKang Therapeutics. Prior to NiKang, he held regulatory and quality positions at Peloton Therapeutics and Reata Pharmaceuticals.

Steve received his undergraduate degree in chemistry from Texas A&M University in 1993.