Senior Regulatory Consultant / Toxicologist - GRAS & NDI Expert

About This Role

This senior-level role involves serving as a premier technical authority and trusted advisor to clients, leading scientific safety assessments, evaluating manufacturing chemistry, authoring high-impact regulatory submissions, and providing strategic roadmaps for novel food and dietary ingredients across human and veterinary applications. You will bridge the gap between complex science, rigorous toxicology, and commercial market access, helping clients determine optimal regulatory pathways while delivering exceptional consulting service.

Responsibilities

• Conduct feasibility assessments and gap analyses to determine whether novel ingredients require a GRAS (Generally Recognized as Safe) notification, an NDI (New Dietary Ingredient) notification, or alternative pathways
• Critically evaluate published and unpublished toxicology, safety, and efficacy data
• Design testing cascades and safety profiles to support ingredient safety determinations
• Review and assess detailed manufacturing processes, batch analyses, specifications, impurity and contaminant profiles, and stability data to ensure data integrity for GRAS/NDI dossiers
• Lead the end-to-end authoring, review, and assembly of robust GRAS notices, independent GRAS determinations, and NDI notifications for submission to the U.S. FDA
• Identify, convene, and lead Independent GRAS Expert Panels, managing consensus statements and scientific dialogues through to completion
• Support clients with high-level regulatory compliance, including product classifications, claim substantiation dossiers, and label/ingredient reviews
• Act as a strategic partner to C-suite and R&D leaders, translating complex toxicology and FDA feedback into actionable business strategies
• Support regulatory strategies for both human food/supplements and animal/veterinary feed and ingredient submissions

Requirements

• Ph.D. or Master’s in Toxicology, Pharmacology, Food Science, Biochemistry, or a closely related discipline
• Direct experience working within the U.S. FDA (e.g., CFSAN or CVM) reviewing or evaluating GRAS, NDI, or food additive petitions
• Proven track record authoring and successfully submitting GRAS determinations and NDI notifications with documented FDA engagement
• Strong familiarity with manufacturing flow charts, specs, and contaminant thresholds
• Extensive experience evaluating genotoxicity, subchronic/chronic toxicity studies, safety margins, and ADME profiles
• Exceptional communication skills with the poise and commercial mindset required to manage client relationships and guide them through strategic decision-making

Nice to have:

• DABT certification
• Demonstrated familiarity with U.S. dietary supplement and conventional food regulations, including 21 CFR Part 111, labeling compliance, and structure/function claim substantiation