Lead Regulatory Scientist Medical Countermeasures

Noblis, Inc.; Reston (VA); On-site; USD 116,000 - 181,000; Full time

Job summary

Noblis seeks a Principal Regulatory Scientist in Reston, VA to support national security medical countermeasure programs. You will translate FDA requirements into decision rules for a web-based engine, validate outputs with scientists and software teams, and ensure regulatory accuracy and traceability.

The role involves collaboration across program managers, developers, and regulatory professionals to maintain data integrity and support critical program decisions. U.S.

Qualifications

• PhD/PharmD/MD or related doctoral degree with at least 4 years of relevant experience; master's with at least 6 years may be considered.
• Experience applying FDA regulatory requirements, guidance, and development pathways to assess evidence gaps, regulatory risks, and recommended next steps.
• Ability to evaluate regulatory information and translate findings into defensible decision support for teams and stakeholders.
• Strong technical writing, verbal communication, presentation, facilitation, analytical, and organizational skills.
• U.S. Citizenship with an active secret clearance and ability to obtain a top secret clearance.

Responsibilities

• Review regulatory documentation for medical countermeasure development programs and track regulatory requirements.
• Compile and analyze quality performance data to identify trends and develop tracking tools for stakeholders.
• Distill complex scientific and regulatory information into concise findings for technical and leadership audiences.
• Evaluate data and documentation for accuracy, completeness, currency, provenance, and traceability.
• Support migration, normalization, reconciliation, and validation of information from legacy systems and other data sources.
• Review software prototypes to verify regulatory relevance, usability, and alignment with client requirements.
• Identify opportunities to automate manual processes while preserving scientific quality and data integrity.

Skills

Regulatory science

FDA requirements

Technical writing

Communication

Analytical skills

Education

PhD/MD/DO or related doctoral degree

Master’s degree with 6+ years applicable experience

Job description

Noblis seeks a Principal Regulatory Scientist in Reston, VA to support national security medical countermeasure programs. You will translate FDA requirements into decision rules for a web-based engine, validate outputs with scientists and software teams, and ensure regulatory accuracy and traceability.

The role involves collaboration across program managers, developers, and regulatory professionals to maintain data integrity and support critical program decisions. U.S.