B.2.18 - Senior Regulatory and Quality Affairs Analyst
Background: A Senior Regulatory & Quality Affairs Analyst is needed to provide contracted staffing support to the Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services in Washington, DC. The mission of BARDA is to develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security. For more information on BARDA please visit their website at: http://www.phe.gov/about/BARDA/Pages/default.aspx
Duties of the position: This position will serve as regulatory and quality affairs subject matter expert for multiple BARDA programs and projects involving development and manufacturing of medical countermeasures. This technical advisory support covers the entire range from the inception of requirements to placing FDA-approved products into the strategic national stockpile. 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 the review of contractor submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc.
- Assist in preparation for and participate in regulatory meetings with FDA, as assigned.
- Monitor BARDA supported contractors’ project timelines for key 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 regulatory representative on various cross-functional teams, as assigned
- Maintain current knowledge of the US 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
Must be willing to work full time on-site in Washington D.C.
Education: M.S. in life sciences or related field is highly preferred
- Minimum 15 years of drug or biologics development; Pharmaceutical industry experience in regulatory 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, clinical or process development problems
- Excellent people and communication skills, with a team-oriented leadership style