The Associate Director represents the company to the US FDA for assigned projects and leads the strategic development of documentation submitted to the US FDA. Further, the role represents the NA GRA perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable to develop and maintain US aspects of regulatory strategy documents. In addition, the role prospectively works with the NA labeling strategist and the Global Regulatory Team to develop US prescribing information. The role works with and participates on multi-disciplinary matrixed project teams to successfully meet project deliverables while adhering to regulatory requirements for programs and products. Lastly, the role participates in the development and monitoring of the US regulatory environment and updating of standards and processes related to drug and biologics US regulations.