Otsuka Pharmaceutical Co., Ltd is seeking an Associate Director, Drug Product & Process Development (Small Molecules) to lead late-stage development activities remotely from the United States. You will drive formulation optimization, process characterization, and scalable manufacturing to support Phase 2/3 through commercialization, ensuring QbD-aligned control strategies.
You will oversee regulatory filings (NDA/MAA), health authority interactions, and post-approval lifecycle management while