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 (New 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- Toxicology & Safety Evaluation: Critically evaluate published and unpublished toxicology, safety, and efficacy data; design testing cascades and safety profiles to support ingredient safety determinations.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 & Account Leadership: Act as a strategic partner to C-suite and R&D leaders, translating complex toxicology and FDA feedback into actionable business strategies.
- Cross-Sector Scope: Support regulatory strategies for both human food/supplements and animal/veterinary feed and ingredient submissions.
Qualifications & Background
- Advanced Scientific Degree: Ph.D. or Master’s in Toxicology, Pharmacology, Food Science, Biochemistry, or a closely related discipline (DABT certification is a strong asset).
- Prior FDA Experience Strongly Preferred: Direct experience working within the U.S. FDA (e.g., CFSAN or CVM) reviewing or evaluating GRAS, NDI, or food additive petitions.
- Deep GRAS & NDI Mastery: Proven track record authoring and successfully submitting GRAS determinations and NDI notifications with documented FDA engagement.
- Manufacturing & Toxicological Acumen: Strong familiarity with manufacturing flow charts, specs, and contaminant thresholds, paired with extensive experience evaluating genotoxicity, subchronic/chronic toxicity studies, safety margins, and ADME profiles.
- Client-Facing Leadership: 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): Demonstrated familiarity with U.S. dietary supplement and conventional food regulations, including 21 CFR Part 111, labeling compliance, and structure/function claim substantiation.
Why Join dicentra?
- Fully Remote Flexibility: Work from anywhere with a high degree of autonomy and collaborative virtual infrastructure.
- Industry Leadership: Join a recognized firm with a 25-year legacy of excellence and trust in life sciences and regulatory compliance.
- High-Impact Work: Direct involvement in shaping the market introduction of cutting-edge ingredients and formulations.
- Dynamic Culture: Collaborate with a multi-disciplinary team of passionate regulatory affairs experts, toxicologists, and clinical scientists who value innovation, excellence, and teamwork.
How to Apply
This position is available to fill immediately.
Why join us
Best workplace
We nourish an environment devoted to honesty and fairness, trust and respect. We care deeply for our team members and take work-life balance seriously, allowing our people to decide on a schedule that best fits their life and working preferences.
Best people
We unite cross-industry professionals with a shared passion for improving people’s health and wellness. Our inspiring leaders are accessible and work eagerly side-by-side with individual employees to help them understand and achieve their objectives.
Best opportunities
We encourage our team members to continuously develop and enhance their skills and expertise. We recognize and reward courageous choices and innovative ideas that result in the growth of our people and company, and in the success of our clients.
Become a part of a purpose-driven and future-oriented business that impacts and improves millions of lives worldwide!