Dietary Supplements Toxicology Scientist - Regulatory Review

Guidehouse; Silver Spring (MD); Hybrid; 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

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.