Regulatory Counsel, FDA

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of the authority. Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

View full vacancy announcement here: https://www.fda.gov/media/155912/download

Application Period: February 2, 2022 – February 23, 2022

Area of Consideration: United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.

Position: Regulatory Counsel

Series: AD-0301

Location(s): Silver Spring, MD

Work Schedule: Full Time

Salary: Starting at $126,233

Cures Band(s): Band D

Full Performance Band Level: Band D

Travel Requirements: 25% or less

Bargaining Unit: 3591

Relocation Expenses Reimbursement: You may qualify for reimbursement of relocation expenses in accordance with agency policy.

The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter (OTC) and prescription drugs, including biological therapeutics and generic drugs.

The mission of the CDER Office of Compliance (CDER OC) is to shield patients from poor quality, unsafe and ineffective drugs through proactive compliance strategies and risk-based enforcement actions. As a Regulatory Counsel in the Office of Unapproved Drugs and Labeling Compliance, the incumbent serves as a Subject-Matter-Expert (SME) with responsibilities for protecting the public health of U.S. consumers from unapproved and misbranded drug products through the enforcement of compliance laws and regulations. In this capacity, the incumbent performs substantive activities in major compliance areas involving difficult, complex, controversial, and precedent setting compliance strategies, cases, regulatory actions, policies, guidances, and outreach activities.

Duties/Responsibilities

• Provides regulatory expertise related to unapproved drug products and performs substantive work with a multiplicity of unprecedented and complex scientific topics, including, but not limited to human drugs, misbranding provision of the FD&C Act, emerging technologies, new regulations, and scientific policies. As a SME, the employee provides authoritative advice, guidance and recommendations on drug compliance policies, programs, processes, and proceedings.

• Identifies, assesses, and evaluates drug compliance issues. Informs, consults with, and advises OUDLC management, Office of Regulatory Affairs (ORA), and other multidisciplinary personnel on regulatory, scientific and drug compliance problems and issues discovered during evaluations. Manages, reviews, and prepares final reports including Agency determinations and findings.

• Works independently and with team members to appropriately manage cases including development of strategic plan for investigations, Agency response, and final disposition. The incumbent uses knowledges of a variety of scientific and technical disciplines to carry out assigned tasks; Reports to the Branch Chief on individual work accomplishments, problems, progress in mastering tasks and work processes.

• Makes independent scientific and regulatory judgments on cases. Analyzes problems and develops enforcement and regulatory strategies to address drugs that are misbranded, unapproved, or violate other aspects of the Federal Food, Drug and Cosmetic Act (FD&C Act) using a risk-based methodology.

• Uses resources such as the US Code, Code of Federal Regulations, the Federal Register, and others, to conduct research regarding established precedents to develop and support compliance actions and policies. Interprets and applies existing policies that effect internal and industry program activities and the marketing of regulated products.

• Collaborates with other OUDLC SMEs to develops policy, regulatory and legal analyses. Coordinates and prepares responses to inquiries from industry, congressional, FDA, and other entities pertaining to FDA’s enforcement of laws, regulations, case status, and enforcement policy. May be required to serve as a resource to FDA’s Office of Chief Counsel (OCC) in developing cases for legal proceedings. As a SME, the incumbent may be required to serve as a Federal witness in legal proceedings.

• May conduct briefings, presentations, and meetings for Office, CDER, and Agency officials, regulated industry representatives, trade associations, health professional organizations/ groups, and academia.

• Provides guidance and/or training to regulatory specialists and other professionals within FDA on matters relating to his/her expertise.

Supervisory Responsibilities: n/a

Education Requirement:

Regulatory Counsel – AD 0301

A juris doctorate degree from an accredited institution of higher learning. OPM Occupational Series Qualification Requirements

Professional Experience:

• Master of occupational specialty. Skilled in applying knowledge to all occupation‐related duties and responsibilities.

• Expert knowledge of the various titles of law applicable to the Agency's mission, Federal law governing or affecting the program, Federal regulations, and significant national developments in the field. These laws may include, but are not limited to, the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act or related types of legislation.

• Mastery of other pertinent regulatory information in agency manuals, reference systems, directives, issuances, precedent decisions, court decisions, and commercial publications or a similar background.

• Ability to analyze, evaluate, and interpret complex Federal statutes and regulations or related background. Ability to meet and deal effectively on behalf of the Center with those persons and organizations having business with or who are influenced by Center programs or related background.

To be placed into a Cures position, candidates must meet the following criteria:

1. Scientific, Technical, and Professional Fields

2. Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.

b. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.

To qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.

How to Apply: Submit resume or curriculum vitae with cover letter by February 28, 2022 to: CDER-OC-IO-PMAS-PMT-OUDLC@fda.hhs.gov. Candidate resumes may be shared with hiring official within the Center for Drug Evaluation and Research (CDER) with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. For questions, please contact the CDER OC PMAS OUDLC Team at CDER-OC-IO-PMAS-PMT-OUDLC@fda.hhs.gov. Please reference “Regulatory Counsel vacancy” in the subject.