Full-Time BARDA Senior Regulatory Affairs SME

BARDA Senior Regulatory Affairs Subject Matter Expert

Support BARDA Program Office(s) as subject matter expert in Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (viral, bacterial), Influenza and Emerging Infectious Diseases Division (IEIDD). Develop and manage regulated studies.

Responsibilities:

• Provide subject matter expertise for MCM regulatory approval & licensure/clearance of diagnostics, medical devices, vaccines, & therapeutics.
• Serve as advisor on Technical Evaluation Panels (TEPs).
• Support Program Coordination Teams (PCTs).
• Provide assessments, recommendations, & guidance to PCT & COR.
• Develop cost estimates for notional programs.
• Review study protocols, reports, regulatory documents, proposals, & presentations.
• Develop work products (summary reports, assessment reports, analysis reports, etc.).
• Advise on contractor statements of work.
• Distill complex information into concise summaries.
• Participate in strategic discussions.
• Provide portfolio management & oversight.
• Provide recommendations on Total Life Cycle Cost (TLCC).
• Participate in Market Research.
• Serve as primary interface with BARDA, industry, & FDA.
• Supervise Regulatory Affairs Analysts.
• Support MCM development against public health threats (influenza, chemical, biological, radiological, nuclear).
• Coordinate with program managers, scientists, & other experts.
• Strategize innovative regulatory approaches.
• Advise leadership on programmatic & project challenges.
• Provide training & advisement on regulations & interactions with regulatory authorities.
• Serve as Regulatory Affairs SME for multiple programs & projects.
• Provide scientific/technical/program advice.
• Implement Regulatory plans.
• Develop methodologies & procedures for CBER vaccine & biologics products.
• Oversee cGMP manufacturing facilities.
• Assist with contract compliance.
• Provide conceptual ideas for preparedness & response to emerging diseases.
• Prepare draft Statements of Work (SOW).
• Support technical & cost evaluations for white papers/proposals.
• Support contract initiation & negotiation.
• Draft meeting minutes, trip reports, & technical assessments.
• Review industry partner regulatory strategy & submissions (INDs, Briefing Documents, etc.).
• Monitor industry partner project timelines.
• Participate in cross-functional teams & regulatory interactions with FDA.
• Maintain knowledge of US competitive landscape & regulations.
• Attend industry conferences.
• Provide Regulatory Research & Intelligence support.

Qualifications:

• 15+ years of relevant industry experience at senior regulatory affairs positions.
• Master’s degree or higher in biology, microbiology, chemistry, toxicology, or pharmacy.
• Experience in FDA engagement & regulatory document development.

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