Position: Supervisory Regulatory Counsel  

Pay Plan-Series: AD-0301

Location: Duty station negotiable after selection 

Travel Requirements: <25%

Application Period: December 17, 2021 – January 7, 2022

Salary: Starting at $144,128 (Band E)

Area of Consideration: United States Citizens or Nationals 

Special Notes: This position is being filled under a streamlined 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 this authority. Additional information on 21st Century Cures Act can be found here:
21st Century Cures Act Information.

Introduction

The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.

The mission of the Center for Veterinary Medicine (CVM) is to protect and promote human and animal health. CVM ensures the safety of the American food supply, the safety of animal food and devices, and the safety and effectiveness of animal drugs. Specifically, CVM evaluates new animal drug applications for safety and effectiveness; monitors animal drugs, foods, and devices on the market; evaluates animal food additives for safety and utility; and conducts applied research to further protect human and animal health. As a high-performance organization within the FDA, CVM strives for excellence, innovation, and leadership across all operations, occupations, and grade levels.

The Office of Surveillance and Compliance (OS&C) has primary responsibility for: compliance-related actions, post-approval monitoring, and animal feed safety. OS&C monitors the safety and effectiveness of marketed drugs after they enter the market. Working with the U.S. Department of Agriculture and State agencies, the Office monitors the occurrence of unsafe drug residues in meat, milk, and poultry products. OS&C assures the safety of animal food by reviewing new animal food ingredients, providing oversight of the medicated feeds program, and providing oversight of the feed contaminants program. The Office coordinates enforcement actions against unapproved animal food and drugs that are on the market and that threaten public and animal health. The Office regulates the promotion and advertising of animal drugs to ensure that they are promoted in a truthful and non-misleading way, and each year receives more than 100,000 adverse drug events that are used to provide updated safety and effectiveness information to consumers. 

To learn more about OS&C click here.

Duties/Responsibilities

As a Supervisory Regulatory Counsel you will:

  • Serve as an expert advisor to Office, Center, and Agency staff regarding the laws and regulations relating to pre-market surveillance and compliance activities of regulated animal products.
  • Research and evaluate CVM’s and FDA’s regulatory needs to support and influence legislation and executive initiatives.
  • Supervise the Regulatory Policy Team, overseeing the review and analysis of FDA policies governing Agency and CVM regulated animal products and pertinent surveillance and compliance actions. 

Conditions of Employment

  • U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
  • This position is subject to the COVID-19 vaccine mandate as a condition of employment. In accordance with Executive Order 14043, Federal employees are required to be fully vaccinated against COVID-19 regardless of the employee’s duty location or work arrangement (e.g., telework, remote work, etc.), subject to exceptions that may be required by law. If selected, you will be required to submit proof of vaccination by November 22, 2021 or before your entrance on duty if you are selected after the compliance date. Your HR Consultant will provide a list of documents acceptable as proof of vaccination and instructions for how to submit a request for a legally required exception, if needed, to comply with vaccination requirement.  
  • Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
  • Applicants must meet all qualification requirements by the closing date of this announcement.
  • Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
  • FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
  • Males born after December 31, 1959 must be registered with the Selective Service.
  • One year probationary period may be required. 
  • Financial Disclosure may be required.
  • Ethics Clearance may be required. 
  • Background Investigation/Security Clearance is required. All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time. 

Qualifications

Education Requirements: A juris doctorate degree from an accredited institution of higher learning.

Professional Experience Requirements:     

  • Leading work groups, teams or staff who develop or execute guidance or regulations related to the post-approval of regulated products; 
  • Evaluating the content of new or modified legislation or regulations to provide regulatory or policy advice to senior level management and/or high-level officials; 
  • Providing oversight of the review legal actions, administrative enforcement actions or advisory actions for regulated products.

Additional Desired Experience:

3 years in an attorney or regulatory professional role providing advice on federal regulatory issues with regard to animal products. 

Ethics Clearance Requirements

This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics

Equal Employment Opportunity

The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Equal Employment Opportunity (EEO) for federal employees & job applicants

Reasonable Accommodations Policy

Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job. An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace. An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about disability employment and reasonable accommodations or how to contact an agency.

E-Verify

The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.

How to Apply

Please submit your letter of interest, resume, and copy of transcripts by January 7, 2022 to: [email protected] with the subject line of “Supervisory Regulatory Counsel – Working at CVM—OSC.” 

Announcement Contact

For questions regarding this announcement, please contact [email protected] using the subject line provided above.

Safeguarding human and animal health is what we do. When you join our team, you impact this unique and amazing mission no matter your position. You also join a diverse community of exceptional people who encourage and support everyone to dream, inspire each other, and live our best lives, personally and professionally. When you join CVM, you join an incredible place to work.

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

FDA is an equal opportunity employer.