BARDA Regulatory Affairs Subject Matter Expert

Company Description

BryceTech has partnered with technology and R&D clients to deliver mission and business success since 2017. Bryce combines core competencies in analytics and engineering with domain expertise. Our teams help government agencies, Fortune 500 firms, and investors manage complex programs, develop IT tools, and forecast critical outcomes. We offer clients proprietary, research-based models that enable evidence-based decision-making. Bryce cultivates a culture of engagement and partnership with our clients. BryceTech is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran

Job Description

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.  

Subject Matter Expert Responsibilities – General.

• 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) as well as the research, development, manufacture and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics, preventives, and therapeutics.
• Provide guidance and recommendations on key issues related to the area(s) identified above.
• Review study protocols, study reports, regulatory documents, presentations, proposals, and related documents.
• Provide senior-level briefing(s) to ASPR/BARDA as required.
• Prepare regular reports to ASPR/BARDA management on various technical issues identified as required.
• Provide recommendations for project development level portfolio management and oversight as required.
• Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts.
• Participate in Market Research efforts.

Regulatory Affairs Subject Matter Expert Specific Responsibilities.

• 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.
• 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 scientific/technical/program management advice for assigned programs and projects and work with the Gov./Contractor Project Team to implement Quality Plans for assigned projects.
• Coordinate with program managers, scientists, and other subject matter experts as required.
• Compliance with contract requirements, federal regulations, and guidelines.
• Generate contingency risk reduction plans.
• 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 Quality aspects of BARDA-contractor interactions.
• Review and comment on supported industry partner regulatory strategy, as assigned.
• Review supported company 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 in 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.

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