My client is seeking a Regulatory & Quality Affairs Subject Matter Expert to provide support to the Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services in Washington, DC. In this role, you will serve as regulatory and quality affairs subject matter expert for multiple BARDA programs and projects involving development and manufacturing of medical countermeasure drugs.
- Provide scientific/regulatory affairs/quality support, advice and guidance for medical countermeasure development assigned programs and projects addressing biological threats and emerging infectious diseases
- Provide regulatory oversight for clinical trials and advanced clinical development programs (Phase 1, 2, and 3) in support of FDA approval.
- Support BARDA in the review of contractor submissions of regulatory strategy and documents, including development plans, subcontractor agreements, study protocols and reports.
- Support BARDA in the review of contractor submissions, which may include INDs, NDAs/BLAs, Briefing documents, Orphan Drug Applications, and Marketing Applications, etc.
- Assist in preparation for and participate in regulatory meetings with FDA, as assigned
- 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
Knowledge and Skills:
- A minimum of BS required; MS or PhD in life sciences area highly preferred
- Minimum 15 years of biologics and vaccine development; Pharmaceutical/biotech industry experience in regulatory and/or quality affairs at the VP or Sr. Management levels.
- Expert in biologics and vaccine development with demonstrated experience bringing biologics/vaccines through development into licensure
- Experienced in addressing FDA/CBER hurdles (especially during late stage product development). Demonstrated extensive experience dealing with the FDA and leading regulatory discussions
- Experience performing CGxP audits, clinical site management, handling protocol deviations and related corrective action plans (CAPAs).
- Experience in identifying and resolving quality, regulatory, clinical or process development problems.
- Excellent people and communication skills, with a team-oriented leadership style.