Regulatory Food Safety Toxicology SME
Guidehouse · United States · 1mo ago
Job Family:
Scientist
Travel Required:
Clearance Required:
Our federal client is responsible for protecting public health through the scientific evaluation and regulatory oversight of dietary supplements. Guidehouse is seeking experienced Toxicology Subject Matter Experts to conduct safety evaluations of dietary ingredients and dietary supplement products, perform risk assessments, evaluate scientific evidence, and prepare technically defensible reports supporting FDA regulatory review activities.
What You Will Do:
- Conduct safety assessments and risk characterization of dietary ingredients and dietary supplement products.
- Review and evaluate New Dietary Ingredient Notification (NDIN) submissions.
- Perform systematic literature reviews and evaluate scientific data quality.
- Integrate information from multiple scientific sources to support evidence-based conclusions.
- Conduct dose-response analyses and apply toxicological risk assessment methodologies.
- Prepare technical memoranda, scientific reports, and regulatory review documents.
- Develop data gap analyses and annotated bibliographies.
- Support ingredient prioritization and safety review activities.
- Utilize FDA databases, scientific literature repositories, and toxicological assessment tools.
- Present scientific findings and recommendations to reviewers and technical specialists.
- Complete all required corporate, client, safety, security, and laboratory training requirements.
What You Will Need:
- Ph.D. in Toxicology, Pharmacology or a related scientific disciplines.
- Minimum ZERO- TWO (0-2) years of prior relevant experience
- Demonstrated experience conducting toxicology-based safety assessments.
- Experience performing risk characterization and hazard evaluations.
- Experience conducting literature reviews and evidence synthesis.
- Strong analytical, scientific writing, and communication skills.
- Ability to work independently assess complex scientific data and prepare technical reports.
- Must be able to obtain and maintain a Federal or DoD "public trust"; candidates must obtain approved adjudication of their public trust prior to onboarding with Guidehouse. Candidates with an active public trust or suitability are preferred
What Would Be Nice To Have:
- Experience supporting FDA, USDA, CDC, public health, food safety, or other regulatory laboratory programs.
- Dietary supplement or food safety regulatory review (I.e. NDIN) experience.
- Familiarity with FDA guidance documents and review processes.
- Experience using systematic review methodologies.
- Experience preparing regulatory science memoranda, regulatory science reports and policy-supporting analyses.
What We Offer:
Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.
Benefits include:
Medical, Rx, Dental & Vision Insurance
Personal and Family Sick Time & Company Paid Holidays
Parental Leave
401(k) Retirement Plan
Group Term Life and Travel Assistance
Voluntary Life and AD&D Insurance
Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
Transit and Parking Commuter Benefits
Short-Term & Long-Term Disability
Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
Employee Referral Program
Corporate Sponsored Events & Community Outreach
Care.com annual membership
Employee Assistance Program
Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
Position may be eligible for a discretionary variable incentive bonus
About Guidehouse
Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.
Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.
If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.
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