Regulatory Food Safety Toxicology SME
Guidehouse•Silver Spring, MD
•$65,000 - $108,000•Hybrid
About The Position
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.
Requirements
- 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
Nice To Haves
- 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.
Responsibilities
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Ph.D. or professional degree
