Associate Commissioner Regulatory Policy Coordination; Regulatory Counsel

Duties

Works with the Commissioner, Deputy Commissioners, and senior executives on regulatory policy; co-formulates Agency policy and philosophy; interprets Commissioner directives; and makes broad program decisions, escalating only critical issues.

Advises the Commissioner, Principal Deputy Commissioner, and Deputy Commissioner for OPLIA on major management decisions involving potentially controversial or high-impact issues.

Leads staff overseeing Agency-wide rule making and regulations development; ensures high-quality, timely regulations that advance the Agency's mission; and sets priorities while focusing resources effectively.

Dedicates significant effort to promulgating regulations, securing Department and OMA clearances, and communicating their public health impact to media, Congress, industry, and the public.

Directs the communication of policies and program decisions to the organizational elements of the Agency over which the Associate Commissioner for Policy exercises executive direction and to outside groups affected by FDA regulatory policy.

Evaluates program effectiveness, directs studies to address deficiencies, and makes decisions on organizational and staffing plans and delegations of authority consistent with Commissioner guidelines and Agency needs.

Serves as the Commissioner's representative and spokesperson, clearly and timely communicating FDA policy direction and regulatory responsibilities to outside groups.

Executes special assignments for the Deputy Commissioner for OPLIA, engaging high-level officials across HHS, the Administration, Congress, State and foreign governments, industry, and academic and public health communities.

Builds cooperative relationships with FDA Centers and Offices to ensure consistent policy and rule making approaches and Agency-wide program alignment.

Performs other duties as assigned.