Senior Regulatory Affairs SME

Overview:

LMI is seeking a Senior Regulatory Affairs SME to support the Biomedical Advanced Research and Development Authority (BARDA). This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. You must be a U.S. citizen.

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. 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.

LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.

LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!

• 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.
• 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.
• 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.
• 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 products
• Development 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.

• Minimum of fifteen (15) years of relevant industry experience at senior regulatory affairs positions in the pharmaceutical industry
• Application of master’s degree or higher in biology, microbiology, chemistry, toxicology, or pharmacy with commensurate experience
• Experience in FDA engagement and development of regulatory documents
• Deliverables would include work products related to the development and management of regulatory affairs strategic planning and guidance within current and planned BARDA vaccine, therapeutic, and/or device/diagnostic advanced development and acquisition contracts
• Ability to obtain a public trust clearance. You must be a U.S. citizen.