Senior Regulatory Consultant / Toxicologist - GRAS & NDI ExpertFor over 25 years, has been a trusted global leader in regulatory consulting and clinical research for the life sciences and dietary supplement industries. We partner with innovators worldwide to navigate complex regulatory landscapes, turn scientific rigor into commercial success, and bring safe, compliant products to market. immediate opening Senior Regulatory Consultant / Toxicologist (GRAS & NDI Expert) to join our dynamic, fully remote consulting team. In this senior-level role, you will serve as a premier technical authority and trusted advisor to our clients.

You will lead scientific safety assessments, evaluate manufacturing chemistry, author high-impact regulatory submissions, and provide strategic roadmaps for novel food and dietary ingredients across both You will bridge the gap between complex science, rigorous toxicology, and commercial market access - helping clients determine the optimal regulatory pathways while delivering exceptional consulting service.

Regulatory Pathway Strategy & Feasibility: Conduct feasibility assessments and gap analyses to determine whether novel ingredients require a GRAS (Generally Recognized as Protected) notification, an NDI (New Dietary Ingredient) notification, or alternative pathways.

Toxicology & Safety Evaluation: Critically evaluate published and unpublished toxicology, safety, and efficacy data; design testing cascadesand safety profiles to support ingredient safety determinations.

Manufacturing & Chemistry Assessment: 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.Identify, convene, and lead Independent GRAS Expert Panels - managing consensus statements and scientific dialogues through to completion.

Broader Food & Dietary Supplement Compliance: Support clients with high-level regulatory compliance, including product classifications, claim substantiation dossiers, and label/ingredient reviews.

Client Advisory & Account Leadership: 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.

Advanced Scientific Degree: D. or Master's in Toxicology, Pharmacology, Food Science, Biochemistry, or a closely related discipline (DABT certification is a strong asset). CFSAN or CVM) reviewing or evaluating GRAS, NDI, or food additive petitions. Exceptional communication skills with the poise and commercial mindset required to manage client relationships and guide them through strategic decision-making.

Compliance

Knowledge (Big Plus): S. dietary supplement and conventional food regulations, including 21 CFR Part 111, labeling compliance, and structure/function claim substantiation. Our inspiring leaders are accessible and work eagerly side-by-side with individual employees to help them understand and achieve their objectives. Become a part of a purpose-driven and future-oriented business that impacts and improves millions of lives worldwide! Full-Time Employment Ontario (Fully Remote) #

📌 Senior Regulatory Consultant / Toxicologist - Gras & Ndi Expert (Winnipeg)
🏢 dicentra
📍 Winnipeg