Regulatory Food Safety Toxicology SME

Guidehouse; Silver Spring (MD); On-site; USD 65,000 - 108,000; Full time

Benefits offered by this job

Medical insurance

Rx benefits

Dental & Vision

Parental Leave

401(k) Retirement Plan

Life and AD&D Insurance

Tuition Reimbursement

Job summary

Guidehouse seeks a Toxicology Subject Matter Expert to conduct safety evaluations of dietary ingredients and dietary supplement products for FDA regulatory review. Responsibilities include risk characterization, literature reviews, and preparing technically defensible reports. Travel up to 10% and ability to obtain a Federal public trust are required.

The role requires a Ph.D. in Toxicology or related field and 0–2 years of experience.

Qualifications

• Ph.D. in Toxicology, Pharmacology or related discipline.
• 0–2 years of relevant experience.
• Experience conducting toxicology-based safety assessments.
• Experience risk characterization and hazard evaluations.
• Experience literature reviews and evidence synthesis.
• Strong analytical, scientific writing and communication skills.
• Ability to obtain/maintain Federal or DoD public trust.
• Active public trust or suitability preferred.

Responsibilities

• Conduct safety assessments and risk characterization of dietary ingredients and dietary supplement products.
• Review and evaluate NDIN submissions.
• Perform systematic literature reviews and evaluate data quality.
• Integrate information from multiple scientific sources to support conclusions.
• Conduct dose–response analyses and apply toxicological risk assessment methods.
• Prepare technical memoranda, scientific reports and regulatory review documents.
• Develop data gap analyses and annotated bibliographies.
• Present findings to reviewers and technical specialists.

Skills

Analytical skills

Scientific writing

Communication skills

Independent work

Toxicology risk assessment

Education

Ph.D. in Toxicology, Pharmacology or related discipline

Job description

Job Family: Scientist Travel Required: Up to 10% Clearance Required: Ability to Obtain Public Trust 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.

The annual salary range for this position is $65,000.00-$108,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.

What We Offer:

• 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.

Guidehouse is a global AI-led professional services firm delivering advisory, technology, and managed services to the commercial and government sectors. With an integrated business technology approach, Guidehouse drives efficiency and resilience in the healthcare, financial services, energy, infrastructure, and national security markets. Built to help clients across industries outwit complexity, the firm brings together approximately 18,000 professionals to achieve lasting impact and shape a meaningful future. guidehouse.com