Job Listing
Deputy Office Director (Supervisory Regulatory Specialist)
Food and Drug Administration · Posted 60 days ago
About the Role
This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band F.
What You'll Do
- →Provides assistance to the Office of Drug Security, Integrity, and Response (ODSIR) Director in the management and direction of the development and implementation of the Agency's human drug import, export, recalls, and supply chain integrity compliance and enforcement programs.
- →Manages and coordinates operational issues pertaining to drug recalls and shortages for the Office of Compliance, including coordination of consults from FDA's Drug Shortages Staff, as well as compliance evaluation and actions by the Office of Compliance's Office of Manufacturing Quality and Office of Inspections and Investigations (OII) Field Offices.
- →Provides leadership within the of Office of Compliance for incident response to urgent, emerging, and evolving public health issues related to FDA approved drugs, counterfeit and substandard drugs, and other unapproved drug products.
- →Provides direction to the Division of Supply Chain Integrity, coordinating Office of Compliance efforts to investigate and evaluate incidents to contain the public health exposure to potentially harmful drugs.
- →Works closely with other CDER Offices, including CDER's Counterterrorism and Emergency Coordination Staff, as well as the Agency's Office of Emergency Operations.
- →Supports the development of comprehensive policy and procedural guidelines for handling compliance and enforcement actions related to human drugs.
- →Coordinates Center and OII Field relations and provides support and guidance to field offices on case development, evaluations, and regulatory actions, and ensures uniform interpretation and application of standards.
- →Represents the Center in meetings with top level representatives of other Federal and State agencies to obtain their cooperation on compliance matters of mutual interest.
- →Engages with stakeholders, including top level leaders of regulated industries, to promote compliance.
- →Represents the ODSIR Director in meetings with the Commissioner and other senior Agency officials on compliance matters of major significance.
Requirements
- ✓Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required.
- ✓Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.
- ✓TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements.
- ✓You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.
- ✓Education must be accredited by an accrediting institution recognized by the U.S.
- ✓Department of Education in order for it to be credited towards qualifications.
- ✓Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S.
- ✓Department of Education.
- ✓If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.
- ✓Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file.
- ✓Therefore, you should consider asking the institution to provide the file in a non-secured electronic format.
- ✓Alternatively, you could scan or take a photo of the printed copy of the transcript.
- ✓If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.
- ✓For further information, visit the U.S.
Personality Fit
This role is commonly a great fit for these MBTI types:
Job ID: 8a538a78-4eda-42c1-81a1-9aa1e636b2c0
Posted via USAJobs