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This position is in the Senior Executive Service (SES), a small elite group of senior government leaders who possess a diverse portfolio of experience and the strong skills required to lead across organizations. This dedicated corps of executives is charged with providing strategic leadership and upholding a commitment to public service that transcends loyalty to a specific agency mission or individual profession. As an SES member you will influence the direction of innovation and transformation of the federal government and lead the next generation of public servants.
This position is located in the Office of Regulatory Affairs (ORA), Office of Global Regulatory Operations and Policy (OGROP), within the Food and Drug Administration (FDA) in Silver Spring, Maryland.
The Office of Regulatory Affairs (ORA) is the lead office for all field activities at the FDA. Regulating more than 135, 000 business establishments that annually produce, warehouse, import and transport $1 trillion worth of consumer goods, ORA protects consumers by maximizing compliance of FDA regulated products and minimizing risk associated with these products. More than 4,000 ORA personnel in more than 200 locations work every day to minimize public health risk.
Exceptional recruiting difficulty may result in payment of recruitment or relocation bonus.
This position is also advertised under Job Announcement Number HHS-ES-2013-FDA-, series 301.
The incumbent serves as the Deputy Associate Commissioner for Regulatory Affairs (Deputy ACRA) and principal advisor to the Associate Commissioner for Regulatory Affairs on the full range of ORAs activities including enforcement (regulatory and criminal), implementation of new laws and regulations, and overall strategic planning and prioritization. In this capacity, the incumbent shares fully the responsibility for planning, coordinating, directing and evaluating activities of the ORA. This includes providing executive leadership and managerial direction, through subordinate supervisors, to the Office of Resource Management (ORM); Office of Criminal Investigations; and the Office of Operations (OO). The Deputy ACRA directly supervises the Office of Communications and Quality Program Management (OCQPM), Office of Policy and Risk Management (OPRM), Office of Partnerships (OP), along with the IT, External Relations and Executive Secretariat Staffs in the Immediate Office of the ACRA.
In conjunction with the Associate Commissioner for Regulatory Affairs (ACRA), the incumbent manages and directs over 4,000 employees engaged in regulatory, enforcement, compliance activities and scientific programs which lead to greater public health protection. The incumbent is responsible for providing long range strategic direction for ORA policies and programs including the implementation of the Food Safety Modernization Act and the new Generic Drug User Fees Act. This includes the delegated authority to, and accountability for, making managerial and technical decisions required for successful program execution, administration and management.
As the Deputy Associate Commissioner for Regulatory Affairs, the incumbent provides executive and technical guidance for Agency programs; reviews and evaluates project proposals and plans submitted by ORA Offices/Regions in terms of soundness of scientific/technical reasoning, sufficiency of project proposal, relative priorities, availability of resources, and anticipated results.
The Deputy Associate Commissioner for Regulatory Affairs is the key official participating with the ACRA in carrying out the full range of responsibilities and acts with full authority over the total work of ORA during the ACRA's absence or unavailability.