Regulatory Counsel

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 this 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

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 Office of the Chief Scientist (OCS) is to provide strategic leadership, coordination, and expertise, supporting scientific excellence, innovation, and capacity to achieve FDA's public health mission. The mission of the Office of Counterterrorism and Emerging Threats (OCET) within OCS is to promote health security and protect the nation and the international community from public health threats, including acts of terrorism, epidemics, and disasters.

Duties/Responsibilities

The incumbent is a subject matter expert, responsible for providing regulatory, legal and policy matter expertise to advise and support program function within OCET and OCS. 

Ø Advances Medical Countermeasure Initiative (MCMi) program by helping to ensure that U.S. laws, regulations, and policies help support preparedness and response for potential chemical, biological, radiological, nuclear (CBRN) and emerging disease threats. 

Ø The incumbent handles highly complex and difficult assignments of national scope and significance. The incumbent assumes responsibility for ensuring that Agency regulations and policies related to matters concerning global health security, counterterrorism, and emerging threats (including policies and procedures to facilitate the development and availability of medical countermeasures (MCMs) are consistent with statutory requirements and that they are justified to advance FDA’s public health mission. 

Ø Utilizes regulatory, legal, and policy experience to review and evaluate proposed regulations, policy documents, regulatory actions, and inquiry responses, including Congressional inquiries, that are highly complex and difficult assignments of national scope and significance. 

Ø Develops, drafts, and critically reviews procedurally sound policies and program proposals and decisions in support of Agency activities related to matters concerning global health security, counterterrorism, and emerging threats (including policies and procedures to facilitate the development and availability of MCMs), FDA-related legislation, regulation, guidance documents and interagency documents related to such issues. Convenes and leads workgroups, as necessary, to respond to the development, interpretation and application of such policies and procedures. 

Ø The incumbent consults with staff at all levels of the Agency on issues within area(s) of responsibility to identify areas of disagreement within the FDA such as between Centers and other units of FDA, to resolve disagreements using decision memoranda or through meetings, and to articulate any policy consensus reached through this process. 

Ø Works with FDA offices and Federal partners to implement consistent policy approaches to facilitate the development and availability of MCMs, including through the implementation of FDA’s Emergency Use authorities. Works with medical Center subject matter experts and legal counsel to ensure that use of such authorities are consistent and legally appropriate. Drafts documents related to Emergency Use Authorization, including Federal Register Notices, and replies to correspondence from stakeholders, including public health officials, and other interested persons on issues that are industry-wide in scope or have broad health implications related to interpretations of FDA’s Emergency Use authorities. 

Ø As assigned by the Director of MCM Regulatory Policy, incumbent represents the Agency in liaison activities, meetings and working groups. Works with FDA offices and Federal partners to implement consistent policy approaches on activities related to matters concerning global health security, counterterrorism, and emerging threats (including to facilitate the development and availability of MCMs. 

Ø Makes presentations at conferences and professional meetings before the regulated industry, public health and other government officials, and the medical/scientific community on on issues within area(s) of responsibility. These presentations communicate current policy developments at the Agency and serve as a means of eliciting and alleviating the concerns and criticisms of the regulated industry and FDA government-partners in the MCM enterprise. The incumbent may serve at these meetings as the sole representative of FDA. 

Ø Provides guidance and/or training to regulatory specialists and other professionals within FDA and with Federal, state, local government colleagues external to FDA on matters relating to global health security, counterterrorism, and emerging threats (including policies and procedures to facilitate the development and availability of MCMs) 

How to Apply

All qualified candidates should submit their resume with cover letter and unofficial transcripts (if you have foreign transcripts, please submit foreign transcript evaluation from an accredited company) by February 24, 2023 to: Karen.Drinnon@fda.hhs.gov

How You Will Be Evaluated 

Candidates may be evaluated based on an interview, review of requested work samples, writing samples, most recent performance evaluation(s), professional references, results of an oral presentation or work-related test. Failure to comply with any of the assessment requests will result in removal from further consideration. [Good but perhaps edit as highlighted in green]

Announcement Contact

For questions regarding this Cures position, please contact: Karen.Drinnon@fda.hhs.gov 

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