Regulatory Health Scientist

Persons in this role will be highly motivated, dedicated, professional staff and perform services for CDC's National Center for Emerging Zoonotic Infectious Disease (NCEZID), Regulatory Affairs program in Division of Preparedness and Emerging Infections (DPEI) Regulatory Affairs program.

Locations of support may be CDC Roybal Campus, Atlanta, GA; or CDC Ft. Collins, CO.

DUTIES INCLUDE:

Provide cross-cutting scientific regulatory expertise and consultation regarding medical products (e.g., drugs, biologics and devices) subject to the Food and Drug Administration (FDA) regulations for the Agency.
Provide clinical, scientific regulatory and technical expertise regarding utilization of medical products for various diseases and threat agents with emphasis on public health preparedness and response.
Work with Regulatory Affairs staff members, U.S. Government personnel across CDC and other government agencies as well as non-governmental partners.
Based on clinical, epidemiologic, scientific, and technical understanding of pathophysiology of diseases and clinical conditions resulting from chemical, biological, radiological, and nuclear (CBRN) threats (e.g., anthrax, smallpox, botulism, pandemic influenza, plague, and tularemia) and other diseases of public health importance as well as pharmaceutical and regulatory knowledge of medical products (i.e., drugs, biologics, devices), determine, analyze, develop, and enhance appropriate protocols, documentations, and regulatory applications required for the receipt, storage, distribution, dispensing, and utilization of various medical products stockpiled at the Strategic National Stockpile (SNS) or exclusively available through CDC that are intended to diagnose, prevent or treat conditions or diseases resulting from CBRN threats.
Research and analyze available supportive data to initiate and develop appropriate regulatory mechanisms required (e.g., Investigational New Drug Application, Investigational Device Exemption, 510(k), Pre-Emergency Use Authorization (Pre-EUA)/EUA requests, and/or Emergency Use Instructions) for safe and effective clinical utilization of various medical products in the SNS or exclusively available through CDC.
Evaluate, initiate, and manage protocol amendments, annual reports, safety reports, and correspondences with FDA regarding regulatory applications and submissions for the medical products in the SNS or exclusively available through CDC.
Initiate, research, assess, and evaluate preclinical, clinical, safety, product, and other relevant information (e.g., response strategies, policy) with respect to medical product receipt, storage, deployment and clinical utilization, and perform timely development and revisions of regulatory applications, documents, and/or protocols in accordance with applicable federal regulations, CDC policy, and Regulatory Affairs procedures.
Perform interval reviews of scientific and clinical data, evolving policy, and regulatory framework regarding medical product in the SNS and those exclusively available through CDC and communicate (oral and written) scientific regulatory information and knowledge to CDC subject matter experts, and other stakeholders.
Develop and write a wide spectrum of scientific, technical and regulatory documents, such as but limited to clinical protocols, amendments, informed consents, study reports, standard operating procedures (SOPs), policy documents, manuscripts, communication and training materials for the intended audience regarding medical products for a wide-ranging diseases and threat agents based on relevant data, response strategies, FDA regulations and CDC policy or recommendations.
Provide technical and final review, editing, fact-checking, and proof-reading of a wide spectrum of policy, scientific, and clinical documents generated or consulted by Regulatory Affairs program to ensure accuracy, appropriateness and completeness with respect to clinical, scientific, regulatory and technical contents.
Provide expert scientific regulatory guidance and consultation regarding drugs, biologics and/or devices with a special emphasis on bioterrorism-related and other public health emergency preparedness and response by maintaining working knowledge on relevant policy, regulations and science through independent research, team activities and continuing education.
Contribute to medical countermeasures (MCMs) clinical guidance development that involves researching new and existing data on MCMs; systematic reviews and literature searches to support the development of evidence-based recommendations, including data abstraction and interpretation; designing a clinical guidance development algorithm for biological threats; and preparing and editing clinical guidance documents.
Provide regulatory support and/or serve as Regulatory Affairs Action Officer in the CDC Emergency Operations Center during activations to assist with emergency response related to MCMs.

REQUIRED SKILLS AND EXPERIENCE:

Have in-depth, up-to-date expert knowledge of the FDA regulations regarding drugs, biologics and devices with respect to public health preparedness and emergency response, and provide clinical, scientific regulatory, and technical expertise regarding utilization of medical products for various threat agents.

REQUIRED EDUCATION/CERTIFICATIONS:

Doctoral degree in pharmacy plus at least 10 years of relevant scientific regulatory experience pertaining to medical products with emphasis on public health preparedness and emergency response.

CITIZENSHIP AND CLEARANCE REQUIREMENTS:
Must pass a background check to obtain a common access card (CAC).