As the Director, the incumbent performs substantive work and participates with the ACO by providing leadership and strategic advise in the development, implementation and evaluation of regulations and policies as they relate to ORAs broad national and international programs and activities to ensure the safety, quality, efficacy, and labeling, in their specialized functional areas, such as FDA regulated human drugs, biologics, animal drugs, medical devices and tobacco products.
a. Represents and makes decisions on behalf of the ACO relative to medical products and tobacco programs investigatory operations, including emergency response activities.
b. Represents and speaks for the ACRA in discussions, meetings, conferences, and consultations with top-level departmental and agency officials, national/international industry representatives, academic organizations and groups, foreign officials, members of Congress and/or their representatives, personnel from other executive departments and independent Federal agencies, State and local governmental counterparts and others to secure and provide information concerning critical and significant issues, actions and regulatory activities related to ORA programs and to resolve complex regulatory questions and issues that arise.
c. Participates with the ACRA, senior officials and others in preparing for and/or testifying before Congress on agency regulatory programs and activities. As the focal point of information on ORA regulatory matters, provides authoritative advice, guidance, assistance, interpretations, and recommendations to key agency officials, programs directors, professional personnel, departmental representatives, intra/inter-governmental counterparts and others on problems related to Center regulated products. Furnishes expert advice and comments on matters related to existing programs and regulations and proposes new programs and regulations.
d. Provides leadership and direction on the application of risk management and program evaluation techniques to regulatory compliance activities so that limited resources can provide the most public health promotion/protection at the least cost to the public. Works closely with Agency risk management and program evaluation experts, including those in ORA, the Centers and the Commissioners Office, to identify opportunities for enhanced coordination and better approaches to identifying, prioritizing, and managing risk through field compliance programs, and other approaches including 32 enhanced collaboration within FDA and counterpart governmental agencies, domestically and abroad, and other interested stakeholders.