The Role:The Associate/Director, Regulatory Affairs will join a group of highly motivated, top-notch regulatory professionals and will be a key player in shaping cohesive regulatory strategies across the product pipeline. The Associate/Director, Regulatory Affairs provides regulatory support for oncology products in early-stage and late-stage development through post approval.This role will also serve as the regulatory lead for assigned projects and be responsible for applying regulatory expertise and experience to product development programs. Additionally, the Associate/Director is responsible for the oversight of clinical trial investigational new drug applications (INDs), clinical trial applications (CTAs) and marketing applications – i.e. biologics license applications (BLAs) and new drug applications (NDAs).For more complex applications, this role will lead the finalization of regulatory submission documents and regulatory submissions for completeness and quality in global accordance with regulatory agency requirements, standards, and corporate practices.This position will report to the Director of Regulatory Affairs.What You’ll Do:Working as a regulatory lead to develop regulatory strategies for oncology development programs (which may range from FIH through post-marketing stage)Address complex issues by providing solid regulatory solutions and guidance to the cross-functional teams and senior managementMonitor global regulatory changes that may impact asset developmentProvide tactical support and operational expertise with “hands on” support as neededEnsure compliance of regulatory strategies and submissionsAssess project plans and timelines; manage staff effectively and collaboratively to ensure all projects are appropriately prioritized and key goals are met on timeContribute to the continuous improvement of existing department processes and create new processes to support the evolution of the company
