Regulatory Food Safety Toxicology SME
Core
Conduct safety evaluations and risk assessments for dietary supplements and ingredients to support FDA regulatory review.
Role type
Senior IC toxicology subject matter expert
Builds
Technically defensible safety reports and risk assessments for federal regulatory clients
Domain
Regulatory science / Food safety / Toxicology
Required skills
toxicology-based safety assessments, risk characterization, hazard evaluations, systematic literature reviews, evidence synthesis, dose-response analysis, regulatory science reporting
Preferred skills
FDA/USDA/CDC regulatory review experience, NDIN experience, familiarity with FDA guidance documents, systematic review methodologies
Technologies
FDA databases, scientific literature repositories, toxicological assessment tools
Responsibilities
Conduct safety assessments and risk characterization of dietary ingredients and products; Review and evaluate New Dietary Ingredient Notification (NDIN) submissions; Perform systematic literature reviews and evaluate scientific data quality; Integrate information from multiple scientific sources to support evidence-based conclusions; Conduct dose-response analyses and apply toxicological risk assessment methodologies; Prepare technical memoranda, scientific reports, and regulatory review documents; Develop data gap analyses and annotated bibliographies; Support ingredient prioritization and safety review activities; Utilize FDA databases, scientific literature repositories, and toxicological assessment tools; Present scientific findings and recommendations to reviewers and technical specialists; Complete all required corporate, client, safety, security, and laboratory training requirements.