BryceTech has partnered with technology and R&D clients to deliver mission and business success for nearly 20 years. 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. BryceTech is an Equal Opportunity Employer.
Regulatory Subject Matter Expert

BryceTech is currently looking for a Regulatory Subject Matter Expert. This position will be supporting a high-visibility ASPR client managing over $2B in portfolio value with a variety of needs including support to the project team, acquisition program, and industry outreach efforts. This role will support the development and management of innovative government programs to expand the industrial base for public health sector medical technology. 

  • Provide subject matter expertise in regulatory and quality affairs supporting Medical Counter Measure (MCM) development pathways and DFC contracts
  • Provide support as a regulatory and quality affairs SME on pathways for the successful review of ASPR procurements that require regulatory clearance through Food and Drug Administration (FDA)
  • Responsible for the development of new regulatory policies and procedures in support of ASPR Next BAA and other ASPR Innovation efforts as required.
  • Responsible for the review of ASPR Next BAA White Papers and Full Proposals.
  • Compose inputs and provide revisions to the IBx Director and ASPR Deputy Assistant Secretary for Interagency Policy Committee Executive Orders and other high-level documentation related to synthetic biology, biotechnology, and the bioeconomy.
  • Design, implement, and maintain a comprehensive project, program, and portfolio management strategy in support of the Operations Team and ASPR Next Broad Agency Announcements (BAAs) and support the review of ASPR Next BAA White Papers and Full Proposals 
  • Provide support for Industry Outreach and Response processes including, but not limited to supply chain risk management and emergency management operations and developments as required 
  • Support the review of business systems and tools designed to support client operations
  • Identify business systems and tools to support project, program, and portfolio operations
  • Support Program Management Office operations and serve as the day-to-day point of contact between the client and corporate leadership
  • Master’s degree in Biology, Chemistry or similar field. PhD preferred 
  • 15+ years’ experience with pharmaceutical development and regulatory policy
  • Experience with federal government research and development programs.
  • Excellent verbal and written communications skills
  • Proficiency with all MS Office product and Adobe Acrobat

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.

In September 2021, the US government issued new federal vaccine guidance that certain government contractors must adhere to. BryceTech is a covered federal contractor and so, based on this guidance, our US-based employees are required to be vaccinated, and show proof of vaccination, by Dec. 8, 2021. What does this mean for you as a potential candidate? It means that if you were to join BryceTech, you would need to be fully vaccinated by Dec. 8, 2021, or by your hire date (whichever is later) to be eligible to start in the role. As a condition of employment, you would need to submit official COVID-19 vaccine documentation. BryceTech will consider and review reasonable accommodation requests based on medical or religious grounds for qualified candidates. Please consider this new requirement when applying to BryceTech.

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