Job Overview

Summary

Become a part of the Department that touches the lives of every American!  At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere.  It is the principal agency for protecting the health of citizens.  Join HHS and help to make our world healthier, safer, and better for all Americans.

Who May Apply:  Federal employees with career or career-conditional appointments in the competitive service; former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments; displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) and the Interagency Career Transition Assistance Program (ICTAP); veterans who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service; Military Spouses; PHS Commissioned Corps Officers; and individuals with disabilities.

This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Silver Spring, MD. 

This vacancy covers the Office of Scientific Investigations (OSI) and Office of Unapproved Drugs & Labeling Compliance (OUDLC), Silver Spring, MD.

The Office of Scientific Investigations (OSI) develops policies, surveillance activities, and compliance strategies relating to nonclinical and clinical drug product studies, bioequivalence studies, human subject protections, post-market Adverse Drug Experience reporting requirements, Risk Evaluation and Mitigation Strategies, and commitments for Postmarketing Requirements.

The Office of Unapproved Drugs & Labeling Compliance (OUDCL) develops policies and compliance strategies for protecting the public health by assuring compliance with the new drug and misbranding requirements of the Federal Food, Drug and Cosmetic Act.

This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-DE-13-924249 under competitive procedures.  Please review that announcement to see if you are eligible for consideration under competitive procedures.  NOTE:  Applicants must apply separately for each announcement in order to be considered.


This announcement may be used to fill multiple positions in multiple locations.

Duties

The incumbent will serve as a Senior Regulatory Counsel resolving a broad range of legal/regulatory issues concerning the application of Food and Drug Administration's enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the federal government.

Work with the team and the Division to develop and revise policies, programs,  regulations, and guidance documents involving the most complex and highest priority matters affecting drug compliance.

Perform legal/regulatory reviews of petitions raising issues that have an industry-wide effect, as well as those that pertain to the marketing status of individual products.

Drafts and performs legal/regulatory reviews of action packages for enforcement actions, including Warning Letters and seizure and injunction referrals.

Make presentations at conferences and professional meetings in the U.S. and overseas before the regulated industry and the professional community on the applicable regulations and policies.