Senior Director, Head of US Regulatory Affairs Policy & Intelligence (Washington, United States, Washington, 20001)

The organization seeks a Senior Director to lead US Regulatory Affairs Policy & Intelligence, focusing on shaping regulatory outcomes for generics, biosimilars, and innovative medicines. This role involves developing and executing the US regulatory policy strategy, engaging with FDA leadership, and advocating for timely patient access to medicines. Key responsibilities include overseeing regulatory intelligence activities, managing user fee program strategies, and representing the organization in trade associations. Candidates should possess an advanced degree and 12-15 years of relevant experience, including substantial engagement with FDA and expertise in US regulatory frameworks.