BARDA Senior Regulatory Affairs Program Manager

Background. In 2006 the Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. The BARDA model’s success is codified in 1) 60+ Food and Drug Administration (FDA) approvals, licenses, and clearances, 2) 101 Biomedical products supported for COVID-19 response, and 3) 136 BARDA-supported COVID-19 partnerships. This success centers on BARDA’s public-private partnerships, which have accelerated the development of Medical Counter Measures (MCM) vital to our National Security. BARDA provides its partners critical capability and technical support needed to accelerate MCM regulatory approval and deployment, including support for advanced research and development (AR&D), FDA licensure, and clinical use.  Program Manager Responsibilities - General. Provide concept ideas for BARDA Program Division(s); Prepare draft work statements (SOW, SOO, PWS) for solicitations [Request for Information (RFIs), Request for Proposals (RFPs), Sources Sought Notices (SSN), et al].Review and advise on contract proposals (formally and informally submitted), as requested.Provide project development level portfolio management and oversight.Provide program level portfolio management and oversight.Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts.Assist in contract negotiations on technical matters, as requested.Deliver briefings on relevant subject matter for ASPR/BARDA Senior Leadership and serve as scientific and technical representative for the Program Office(s) concerning the project management of the advanced development, licensure, and acquisition(s) of medical countermeasures, including regulatory and clinical pathways and establishment of manufacturing capacity.Senior Regulatory PM Specific ResponsibilitiesSupervisor for multiple Regulatory Affairs Program Managers.Primary point of contact for BARDA senior and executive leadership on regulatory matters.Develop and execute long-term strategic plans to achieve organizational goals, including developing a strategic plan for the entire department or team.Establishing standards for performance and measuring progress towards goals, then communicating results to stakeholdersLeading teams of project managers and other team members to ensure projects run smoothly and on time.Managing complex, multi-faceted projects that require extensive planning, coordination, and communication with multiple departments within an organization.Determining how best to allocate resources across multiple projects or initiatives based on available funding and personnel.Analyzing data to identify problems and propose solutions.Develop and implement processes and procedures to ensure efficiency and consistency in operations.Provide subject matter expertise in regulatory affairs supporting MCM development pathways.Strategize innovative regulatory approaches to MCM development against emerging threats.Advise regulatory and BARDA senior leadership on critical programmatic and project level regulatory challenges.Provide training and advisement to BARDA staff on regulations, authoring regulatory documents, and interactions with regulatory authorities.Stay up to date on all applicable FDA regulations and guidance documents.Serve as the primary point of contact for other internal/external contributors to the FDA submissions.  This includes direct communications and meetings about the project with regulatory compliance, scientific review committees, the manufacturing sites, the hospital-based research administration, and other entities on campus as needed. Serve as the primary point of contact with external entities, such as outside suppliers of materials, and FDA. Meet regularly with the USG program management and study teams to review content and progress of application packages to various branches of FDA.Provide expert regulatory guidance and support and define regulatory strategy for FDA submissions and interactions in accordance with FDA regulations and guidelines.Ensure all required documentation and sections/modules for submissions to FDA are complete and formatted per FDA requirements.Identify missing or incomplete documentation, track and manage requests for outstanding documentation, and perform submissions throughout the project’s lifecycle to FDA per agency’s requirements.Manage the submission of expedited and routine reports to FDA in accordance with applicable regulations, including authoring all FDA communications, compiling required documentation, and adhering to mandatory timelines.Submit single patient Compassionate Use requests to various branches of FDA, and to internal entities per institutional policies.Maintain and track document version history throughout the IND/IDE’s life cycle to ensure correct and consistent content is provided for review to all internal and external entities.Identify and elevate barriers delaying any FDA submissions, identify solutions, and implement within complex program processes.Ensure accuracy and completeness of Trial Master Files for projects under IND/IDE Office oversight.Lead process improvement initiatives and implement changes to program as needed.Develop and maintain Standard Operating Procedures, work instructions, educational resources and training for IND/IDE Office team members, investigators, and their research teams.