Senior Regulatory Consultant / Toxicologist - GRAS & NDI Expert
For over 25 years, dicentra 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.
To support our continued growth and meet high client demand, we have an immediate opening for an experienced Senior Regulatory Consultant / Toxicologist (GRAS & NDI Expert) to join our dynamic, fully remote consulting team.
The Opportunity
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 human and veterinary applications.
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.
Key Responsibilities
Regulatory Pathway Strategy & Feasibility:



Conduct feasibility assessments and gap analyses to determine whether novel ingredients require a GRAS (Generally Recognized as Safe) notification, an NDI (Recent Dietary Ingredient) notification, or alternative pathways.
Toxicology & Safety Evaluation: Critically evaluate published and unpublished toxicology, safety, and efficacy data; design testing cascades and safety profiles to support ingredient safety determinations.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.
Dossier Preparation & Submission: 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.
Expert Panel Coordination: 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 &

📌 Senior regulatory consultant (Winnipeg)
🏢 dicentra
📍 Winnipeg