Shionogi Inc.
Florham Park, NJ
Overview The Director, Regulatory Affairs leads the development and execution of global regulatory strategies for assigned development programs and U.S. regulatory strategies for marketed products. The role is accountable for integrating regulatory requirements, business objectives, and risk considerations into development plans to support successful product development, regulatory submissions, and lifecycle management.Working independently, the Director serves as the Regulatory Affairs lead for assigned products, partnering with cross-functional teams to provide strategic regulatory guidance, manage regulatory submissions and agency interactions, and ensure timely delivery of regulatory objectives. The Director represents Regulatory Affairs in program-level decision-making, proactively identifies regulatory risks and opportunities, and contributes to the successful advancement and maintenance of development programs while ensuring compliance with global regulatory requirements.A...