Full-Time RegOps Specialist SME

RegOps Specialist SME

Background: The Center for Biomedical Advanced Research and Development Authority (BARDA) develops vaccines, drugs, therapies, and diagnostics for public health emergencies (CBRN, PI, EID). It partners with industry to advance medical countermeasures.

General SME Responsibilities:

• Support BARDA Program Office(s) as a subject matter expert (Chemical, Radiological/Nuclear Threats, Burn & Blast, Biological, Influenza, Emerging Infectious Diseases).
• Advise on research, development, manufacture, and regulatory approval of medical countermeasures (diagnostics, devices, vaccines, therapeutics).
• Provide guidance and recommendations on key issues.
• Serve as advisor on Technical Evaluation Panels (TEPs): white papers, technical proposals, budget proposals.
• Participate as subject matter expert on Program Coordination Teams (PCTs).
• Provide expert assessments, recommendations, and guidance.
• Develop work products (expert reports, analyses, manuscripts).
• Advise federal staff on Contractor proposed statements of work, and suggest improvements.
• Distill complex information into concise summaries (risk/benefit analyses).
• Participate in strategic discussions, building new program areas.
• Provide recommendations for portfolio management and oversight.
• Recommend or advise on Total Life Cycle Cost (TLCC) efforts.
• Participate in Market Research efforts.

Responsibilities specific to RegOps:

• Follow FDA submission requirements.
• Provide subject matter expertise for eCTD submissions (amendments, original filings).
• Coordinate publishing and submitting of electronic dossiers and documents.
• Liaise with Regulatory Affairs Project Managers and CROs.

Requirements:

• Bachelor's degree or equivalent.
• 10+ years progressive experience in leading regulatory operational activities (drugs, biologics, devices).
• Expert knowledge of FDA submission types and eCTD specifications.
• Experience with electronic publishing software and advanced PDF processing.
• Knowledge of FDA and ICH content requirements.
• Understanding of the eCTD structure and US publishing guidance.
• Superior competency in MS Word.

Preferred Skills:

• Superior competency in Adobe Acrobat and ISIToolbox or other PDF toolset(s).
• Ability to build XML documents using Lorenz or similar software.
• Experience with Accenture Starting Point.

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