Background. In 2006 the Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. The BARDA model’s success is codified in 1) 60+ Food and Drug Administration (FDA) approvals, licenses, and clearances, 2) 101 Biomedical products supported for COVID-19 response, and 3) 136 BARDA-supported COVID-19 partnerships. This success centers on BARDA’s public-private partnerships, which have accelerated the development of Medical Counter Measures (MCM) vital to our National Security. BARDA provides its partners critical capability and technical support needed to accelerate MCM regulatory approval and deployment, including support for advanced research and development (AR&D), FDA licensure, and clinical use.  General SME Responsibilities:Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology. Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning) Provide guidance and recommendations on key issues related to the area(s) identified above.Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.Participate as subject matter experts on Program Coordination Teams (PCTs).Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed.Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise. Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work. Experience distilling complex information into informative and concise summaries, including providing risk/benefit analyses and balanced recommendations. Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space. Provide recommendations for project development level portfolio management and oversight as required. Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.Senior Regulatory Affairs Subject Matter Expert Specific Responsibilities.Serve as the primary interface with BARDA, industry and FDA senior leadership on regulatory affairs matters.Supervise less experienced Regulatory Affairs Analysts.Provide subject matter expertise in regulatory affairs supporting Medical Countermeasures (MCM) development pathways against potential public health threats, to include natural occurring epidemic threats such as influenza as well as chemical, biological, radiological, and nuclear threats. These technologies/products cross the gamut of vaccines, drugs, and devices.Coordinate with program managers, scientists, and other subject matter experts as required.Strategize innovative regulatory approaches to MCM development against emerging threats.Advise regulatory and BARDA senior leadership on critical programmatic and project level regulatory challenges.Provide training and advisement to BARDA staff on regulations, authoring regulatory documents, and interactions with regulatory authorities.Serve as a Regulatory Affairs Subject Matter Expert for multiple programs and projects involving development and manufacturing of vaccines and other countermeasures for influenza and emerging infectious diseases.Provide scientific/technical/program management advice for assigned programs and projects and work with the Government/Contractor Project Team to implement Regulatory plans for assigned projects.Development of methodologies and procedures particular to CBER vaccine & biologics productsDevelopment and management of regulated studies.Oversee validation and operation of cGMP manufacturing facilities for vaccines and biologics.Assist in the compliance with contract requirements, federal regulations, and guidelines.Provide conceptual ideas and insights for preparedness and response to emerging infectious diseases.Prepare draft Statements of Work (SOW) for upcoming Requests for Proposals (RFP) and support technical and cost evaluation for white papers/proposals.Support contract initiation/negotiation efforts. Participate in contract kick-off and ongoing meetings at supported company sites.Draft meeting minutes, trip reports, and technical assessments and recommendations on the Regulatory aspects of BARDA-contractor interactions.Review and comment on supported industry partner regulatory strategy, as assigned.Review supported industry partner submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc.Monitor supported industry partner project timelines for FDA submission.Participate or act as regulatory representative on various cross-functional teams, as assigned.Participate or lead regulatory interactions with FDA, as assigned.Maintain knowledge on the US competitive landscape, regulatory environment, regulations, and guidance.Attend and participate in industry conferences on BARDA’s behalf.Provide Regulatory Research and Intelligence support for team as assigned.
