The incumbent serves as the Director, Office of Food and Feed Operations in the Office of Operations (OO) for the Office of Regulatory Affairs (ORA) in the Office of Global Regulatory Operations and Policy (OGROP). As the Director, the incumbent serves as the Senior Food and Feed Operations Officer who will be a key member of the senior management team of the Assistant Commissioner for Operations (ACO), which has responsibilities for decision making processes and leads discussions and decision-making concerning ORA plans, programs, and activities, both during strategic planning sessions and in the actual determination, allocation, and administration of ORA program segment(s), functions, and activities.
The incumbent provides expert advice and counsel concerning approaches and options that are sound and feasible in relation to ORA's regulatory goals and objectives. As the Senior Food and Feed Operations Officer, the incumbent serves as the principal advisor to ACO and ACRA and is recognized as the person who can speak authoritatively for the ACO and ACRA on matters pertaining to the OFFO programs.
The incumbent represents the Agency, ACRA and/or ACO in meetings, conference, and committees involving policy and other matters pertinent to the Office of Food and Feed Operations programs; provides input from ACRA concerning critical and significant issues and regulatory activities to resolve regulatory questions and issues relating to food and feed products; and coordinates with FDA Centers, ORA HQ components, ORA Regional and District Offices, other Federal agencies, international, State and local governments concerning the interpretation of regulatory requirements, impacts, and other issues.
The incumbent represents ACRA and/or ACO in dealing with and and negotiating with representatives of Congress; HHS Operating Divisions, other Federal agencies; State, local, and, at times, foreign governments; the regulated industry; professional and industry organizations; and public interest groups and provides authoritative counsel and guidance concerning critical and significant regulatory questions and issues related to food and feed products.
Oversees the implementation of new laws and regulations which impact the mission of ORA and OFFO. This includes responsibility for the initiation and implementation of new policies, systems, and procedures.
The incumbent is responsible for analysis of the impact of proposed changes to Agency laws and regulations, policies, and procedures which affect the functions, program segment(s), and activities of ORA's HQ and field offices that are involved with FDA's/ORA's nationwide regulatory and compliance operations as they relate to food and animal feed programs and operations. Identifies changes and additions to the functions, program segment(s), and activities of ORA necessary to implement new legislation or regulations, and develops various scenarios for dealing with expansion or contraction of ORA functions, program segment(s), and activities in relation to investigational and regulatory efforts in the Food and Feed Operations programs.
The incumbent oversees, monitors, evaluates and provides guidance on the effectiveness of Regional and District Office investigational, regulatory and compliance activities related to food and feed program operations. Provides guidance on matters which cannot be resolved at the local level and coordinates efforts among the various offices.