Associate Director

Otsuka Pharmaceutical Companies (U.S.) is seeking a highly motivated Associate Director, Global Labeling to join their innovative pharmaceutical development team. This critical role involves leading cross-functional teams to meticulously develop and maintain global labeling strategies and documentation. The position requires ensuring strict compliance with all relevant regulations and actively driving continuous improvement within labeling processes. Key responsibilities include acting as the Global Labeling Strategy Lead for assigned compounds, preparing, reviewing, and updating content for Company Core Data Sheets (CCDS), local labeling, and associated components. You will lead cross-functional labeling teams to ensure alignment of content and strategy, partnering closely with Global Regulatory Affairs to align labeling with global product strategy and key messaging. The role also entails evaluating and communicating risks associated with CCDS content updates, driving package artwork development and maintenance, and supporting global Health Authority interactions, including submissions, responses, and negotiations. A deep understanding of current labeling content requirements, regulations, and guidance is essential to ensure accuracy, consistency, and compliance across all assigned compound labeling documents. The Associate Director will also assess competitor labeling and trends to propose optimized content, support the creation and submission of SPLs, manage drug listing and establishment registration activities, and ensure accuracy of FDA postings. Maintaining labeling documents in document management systems, managing label review and approval processes, and contributing to periodic reports are also key functions. This role supports inspection readiness activities, represents Global Labeling on various product-specific teams, and collaborates with global Otsuka colleagues and partners. The candidate will develop clear communications for senior management and stakeholders to streamline label development and approvals, and will contribute to the continuous improvement of Global Labeling policies, processes, quality, and system tools.