Senior Regulatory Affairs & Quality SME Development of Influenza Countermeasures

Retained Search

Our client has retained us for a newly created Senior Regulatory and Quality Affairs Subject Matter Expert Position.  In this role, you will support the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services in Washington, DC.  The Senior Regulatory Affairs SME will be an integral part of the BARDA mission to support the advanced development and procurement of drugs, vaccines, and other products considered national health security priorities.  This position will serve as Regulatory Affairs and Quality Affairs subject matter expert for multiple BARDA programs and projects involving developing and manufacturing vaccine medical countermeasures specific to pandemic influenza.

Specific duties may include but are not limited to:

• Provide scientific/regulatory affairs/quality support, advice, and guidance for assigned programs and projects, including emerging infectious diseases.
• Monitor 21CFR compliance on assigned programs and projects.
• Support BARDA in the review of contractor submissions of Regulatory strategy and documents, including development plans, study reports, study protocols, and reports.
• Support BARDA in reviewing contractor submissions, including INDs, Briefing Documents, Orphan Drug Applications, Marketing Applications, etc.
• Assist in preparation for and participate in Regulatory Affairs meetings with FDA, as assigned.
• Monitor BARDA-supported contractors’ project timelines for critical Regulatory and Quality performance measures, and provide recommendations to overcome challenges and reduce program risk.
• Participate in site visits/audits to review and monitor vendor progress toward completion of contract milestones.
• Assist Project Team and BARDA-supported contractors to develop and manage strategy, protocols, and FDA applications for Emergency Use Authorizations.
• Participate or act as the Regulatory Affairs representative on various cross-functional teams as assigned.
• Maintain current knowledge of the U.S. competitive landscape, Regulatory environment, regulations, and guidance.
• Provide Regulatory opinions on specific issues.
• Support contract initiation/negotiation efforts by providing Regulatory and Quality assessments of white papers and proposals to BARDA.
• Provide Regulatory advice and counsel on draft Statements of Work (SOW) for upcoming Requests for Proposals (RFP) and support technical and cost evaluation for white papers/proposals.
• Draft meeting minutes, trip reports, and technical assessments and recommendations (including Regulatory opinions) on the Regulatory aspects of BARDA-contractor interactions.

Desired Experience:

• M.S. or higher in life sciences or a related field is highly preferred.
• Minimum 15 years of drug or biologics development; Pharmaceutical industry experience in Regulatory Affairs and/or Quality affairs at the Director, VP, or Sr. Management levels.
• Experienced in addressing FDA/CBER hurdles (especially during late-stage product development).
• Experience in identifying and resolving Quality, Regulatory Affairs, clinical, or process development problems for seasonal or pandemic influenza vaccines.
• Experience with and understanding of influenza risk management, including seasonal influenza and potential pandemic risk posed by influenza A viruses that circulate in animals but not humans.
• Excellent people and communication skills, with a team-oriented leadership style.

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