Full-Time BARDA Senior Regulatory Affairs SME

BARDA Senior Regulatory Affairs Subject Matter Expert

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. BARDA's success includes over 60 FDA approvals/licenses/clearances and 101 biomedical products supported for the COVID-19 response.

General SME Responsibilities:

• Support BARDA Program Offices as a subject matter expert in various threat areas (chemical, radiological/nuclear, burn/blast, biological).
• Provide guidance and recommendations on key issues related to MCM development.
• Serve as advisor on Technical Evaluation Panels (TEPs).
• Participate in Program Coordination Teams (PCTs).
• Provide expert assessments, recommendations, and guidance, including educational materials.
• Provide subject matter expertise and advisory support to federal staff.
• Review and comment on study protocols, reports, and regulatory documents.
• Develop work products (expert reports, analysis, etc.) related to BARDA’s mission.
• Advise federal staff on contractor proposed statements of work.
• Participate in strategic discussions and program development.
• Provide recommendations for project portfolio management and oversight.
• Provide recommendations on Total Life Cycle Cost (TLCC) efforts.
• Participate in Market Research.

Specific Responsibilities:

• Serve as 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 MCM development, including influenza and emerging threats.
• Coordinate with program managers, scientists, and subject matter experts.
• Strategize innovative regulatory approaches.
• Advise regulatory and BARDA senior leadership on challenges.
• Provide training and advisement to BARDA staff.
• Serve as a Regulatory Affairs SME for multiple programs.
• Provide scientific/technical/program management advice.
• Development of methodologies and procedures for CBER vaccine/biologics products.
• Development and management of regulated studies.
• Oversee validation and operation of cGMP manufacturing facilities.
• Assist in contract compliance.
• Provide conceptual ideas for preparedness and response.
• Prepare draft Statements of Work (SOWs).
• Support contract initiation/negotiation.
• Participate in contract kick-off and ongoing meetings.
• Draft meeting minutes, trip reports, and technical assessments.
• Review and comment on industry partner regulatory strategy.
• Review industry partner submissions (INDs, Briefing Documents, etc.).
• Monitor industry partner project timelines.
• Participate in cross-functional teams and regulatory interactions with FDA.
• Maintain knowledge on US competitive landscape and regulations.
• Attend industry conferences.
• Provide Regulatory Research and Intelligence support.

Requirements:

• 15+ years of relevant industry experience in senior regulatory affairs.
• Master's degree or higher in relevant fields (biology, microbiology, chemistry, toxicology, or pharmacy).
• Experience in FDA engagement and regulatory document development.

Deliverables: Regulatory affairs strategic planning and guidance within BARDA contracts.

Location: 100% Remote

Benefits: Competitive salary, comprehensive health plan, company-paid life & disability insurance, 401(k) plan with match, and educational reimbursement program.

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