Provides global regulatory intelligence expertise to regulatory affairs, pre-clinical, clinical, and commercial areas for investigational and marketed products. Ensures that regulatory/competitive intelligence, or scientific/regulatory information searching, summarization, assessment and dissemination are provided to the Otsuka organization.
Proactively monitors emerging external scientific and regulatory trends, approvals, and strategies to inform and influence the development of regulatory strategies and policies both across and within disease therapy areas. Works with Global Regulatory Management to provide both routine and ad hoc requested information including implementing a commenting process on health authority guidance and directives.
Leads development of Policy or Position Papers.
Supports or leads projects and non-project activities e.g. SOP/standards development, organizational initiatives, as needed. etc.
Associate Director - Bachelor's degree required, advanced preferred (PharmD, MLS, PhD, MD etc.) with a minimum of 15 years of experience in regulatory intelligence, regulatory affairs, and/or scientific/regulatory information searching, summarization, assessment and dissemination
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit www.otsuka-us.com.
OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/.