Regulatory Compliance Reviewer
Core
Evaluate dietary supplement labels, manufacturing processes, and structure/function claims for compliance with FDA regulations and CGMP requirements to support federal public health oversight.
Role type
Regulatory Compliance Reviewer (Scientist)
Builds
Regulatory review memoranda, objection letters, warning letter language, and export certificates for dietary supplements.
Domain
Food & Beverage / Regulatory Science / Public Health
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA food labeling regulations knowledge, dietary supplement CGMP requirements knowledge, regulatory review documentation preparation, scientific writing, analytical skills, market surveillance techniques
Preferred skills
FDA/USDA/CDC program support experience, Structure Function Claim Notification (SFCN) review, internal review systems familiarity, manufacturing compliance review experience
Technologies
FDA databases, web-based analytical tools
Responsibilities
Evaluate dietary supplement labels for FDA compliance, review structure/function claim notifications, assess manufacturing processes for CGMP compliance, conduct market surveillance to identify violations, analyze inspection findings and prepare memoranda, draft regulatory correspondence and warning letter language, apply statutes and scientific literature to review activities
Seniority
Junior to Mid-level, hands-on IC
