Background: Two Senior Regulatory & Quality Affairs Analysts are 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: These two positions will serve as regulatory and quality affairs subject matter experts 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 medical countermeasure development & manufacturing programs and projects addressing CBRN threats, emerging infectious diseases and antibiotic resistant bacteria.
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 of regulatory strategy and documents, including development plans, subcontractor agreements, study reports, 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.
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
Maintain active surveillance program of regulatory environment, the US competitive landscape, regulations and guidance
Provide written 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
Provide regulatory training and/or mentorship to BARDA staff
M.S. or Ph.D. 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.
Expertise in drug development of antimicrobial therapies, particularly antibiotics is a strong plus
Experienced in addressing FDA hurdles for approval and licensure of products regulated by CDER or CBER (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
Conceptual MindWorks, INC is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Conceptual MindWorks, Inc. (CMI) is a diversified basic and applied research, consulting, and software engineering company with over 26 years of providing health-related software, bioinformatics, biotechnology, scientific, and technical solutions to the public and private sectors.