BARDA Senior Regulatory Affairs Program Manager

Company Description

BryceTech. BryceTech has partnered with technology and R&D clients to deliver mission and business success since 2017. Bryce combines core competencies in analytics and engineering with domain expertise. Our teams help government agencies, Fortune 500 firms, and investors manage complex programs, develop IT tools, and forecast critical outcomes. We offer clients proprietary, research-based models that enable evidence-based decision making. Bryce cultivates a culture of engagement and partnership with our clients. Bryce Space and Technology is an Equal Opportunity Employer.

BryceTech offers a full range of benefits, including competitive salary, a comprehensive health plan including dental and vision coverage, company-paid life & disability insurance policies, 401(k) plan with company match, and an educational reimbursement program.

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.  

Job Description

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 Responsibilities

• Supervisor 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 stakeholders
• Leading 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 entiti