Principal Regulatory Scientist

Noblis•Reston, VA

4d•Onsite

About The Position

This position is for upcoming work and is contingent upon task award/funding. This will be based out of Reston, VA. Noblis is seeking a Principal Regulatory Scientist to support critical national security programs. In this role you will help ensure regulatory and product information is accurately represented in a secure database and web-based application. This system supports programmatic and regulatory decision-making for medical countermeasures intended to prevent, diagnose, or treat the effects of chemical, biological, radiological, nuclear, emerging infectious disease, and other operational threats. The Principal Regulatory Scientist will work closely with client program managers, product developers, scientists, regulatory professionals, data specialists, software engineers, and web application developers to translate FDA regulatory requirements, development milestones, evidence standards, and program risks into decision rules, data requirements, and logic for a web-based decision support engine. You will also collaborate with software developers, data architects, and end users to validate recommendations, test decision pathways, and ensure outputs are scientifically accurate, traceable, and appropriate for medical countermeasure development.

Requirements

PhD., Pharm.D., M.D., or other relevant doctoral degree in toxicology, chemistry, biochemistry, biomedical engineering, regulatory science, or a related scientific discipline and at least 4 years of relevant experience. A master’s degree in a relevant field may be considered with at least 6 years directly applicable experience.
Demonstrated experience applying FDA regulatory requirements, guidance, and development pathways to assess evidence gaps, regulatory risks, and recommended next steps for medical countermeasure programs.
Ability to evaluate nonclinical, clinical, CMC, and regulatory information and translate complex findings into clear, defensible decision support for multidisciplinary program teams and government stakeholders.
Strong technical writing, verbal communication, presentation, facilitation, analytical, and organizational skills.
Must be a US Citizen with an active secret clearance, and ability to obtain a top secret clearance.

Nice To Haves

Direct experience developing or evaluating medical countermeasures for chemical, biological, radiological, nuclear, emerging infectious-disease, or operational threats.
Experience supporting a Department of War/Department of Defense, Department of Health and Human Services, or other federal medical countermeasure organization.
Experience with FDA’s Animal Rule and development programs in which human efficacy studies are unethical or infeasible.
Experience with pre-EUA or EUA submissions and emergency-preparedness activities.
Experience participating in software user-acceptance testing, requirements traceability, data validation, or quality-assurance activities.

Responsibilities

Review, organize, and track regulatory documentation associated with medical countermeasure development programs, while maintaining awareness of evolving FDA requirements and communicating changes that may affect client programs or information-management needs.
Compile and analyze quality performance data to identify trends and develop tools and systems for tracking performance measures, and interfacing with customers, and various stakeholders to resolve quality problems and provide technical guidance, participating in or leading quality improvement initiatives and program implementations.
Distill complex scientific and regulatory information into concise findings that can be used by technical experts, program managers, senior leaders, and software-development personnel.
Evaluate data and documentation for accuracy, completeness, consistency, currency, provenance, traceability, and appropriate classification.
Support migration, normalization, reconciliation, and validation of information from legacy systems and other data sources.
Review software prototypes and application releases to verify scientific accuracy, regulatory relevance, usability, and alignment with client requirements.
Identify opportunities to automate manual processes while preserving scientific quality, data integrity, traceability, and appropriate human review.