James Ottinger

Biography

 James Ottinger, is a Senior level regulatory professional with over 30 years of global regulatory experience with emphasis on drug development and registration in the U.S., Europe and Japan. Currently responsible for Teva’s Global Regulatory Affairs functions for both generics and branded pharmaceuticals. Teva is the world’s largest generics company with over 1000 drugs approved, and a significant branded portfolio including Copaxone, Azilect, Nuvigil, Provigil, Treanda, ProAir, and Qvar. Mr Ottinger was previously Vice President of Regulatory Affairs at Cephalon, Inc, acquired by Teva in 2012. Prior to joining Cephalon, Mr Ottinger was Vice President of Consulting and Compliance for Premier Research Group, and was responsible for Global Regulatory Affairs, Quality Assurance, Pharmacovigilance, and Medical Affairs. During this five year span, Mr Ottinger lead a team which submitted over 50 INDs and 3 NDAs, including the approval of Exalgo Extended Release Tablets. Mr Ottinger spent over 24 years at Wyeth Research in a variety of regulatory affairs roles, most recently as Global Head of the Neuroscience Therapeutic Area which included responsibility for the blockbuster antidepressant, Effexor XR, as well as the company’s investigational Neuroscience compounds. Mr Ottinger began his career in International Regulatory Affairs focusing on regulatory affairs in Asia.  Specialties: Regulatory Affairs, Generics Regulatory Affairs, U.S. FDA, EMA, CHMP, Japanese PMDA/MHLW, Biosimilars, U.S. INDs, EU CTAs, 505(b)(1) and 505(b)(2) NDAs, BLAs, MAAs, REMS

Research Interest

 Generics Regulatory Affairs