Regulatory Food Safety Toxicology SME
Core
Conduct safety evaluations and risk assessments for dietary supplements and ingredients to support FDA regulatory review.
Role type
Regulatory Food Safety Toxicology SME
Builds
Technically defensible safety reports, risk characterizations, and regulatory review documents for dietary supplement products.
Domain
Food safety / Regulatory toxicology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
toxicology-based safety assessments, risk characterization, hazard evaluation, systematic literature reviews, evidence synthesis, dose-response analysis, scientific writing
Preferred skills
FDA regulatory review experience, NDIN submission 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; 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
Seniority
Mid-level, hands-on IC