The Associate Director, Regulatory Affairs is responsible for developing, implementing and leading both regional and international strategy for assigned projects with various cross-functional teams. This role executes regulatory strategies for earliest possible approvals of the company’s regulatory applications at all stages of development and post approval and addresses the analysis and evaluation of regulatory procedures and changes to ensure attainment of corporate goals. The Associate Director provides guidance for, and may actively contribute to, the development of documents for regulatory agencies e.g. Investigational New Drug applications (INDs)/Investigational Medicinal Product Dossiers (IMPDs)/Clinical Trial Applications (CTAs), and New Drug Applications (NDAs)/Biologics License Applications (BLAs)/Marketing Authorization Applications (MAAs) ensuring that they meet current regulatory requirements and industry standards, are high quality, consistent, complete, and approvable on the first review cycle. This position may supervise or manage others within the Regulatory Affairs skill group.