Regulatory Toxicology Scientist – Dietary Supplements

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

Benefits offered by this job

Medical, Rx, Dental & Vision Insurance

401(k) Retirement Plan

Parental Leave

Tuition Reimbursement

Employee Assistance Program

Transit and Parking Benefits

Job summary

Guidehouse is seeking 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 includes safety assessments, reviewing NDIN submissions, literature reviews, dose–response analyses, and preparing memoranda and regulatory documents.

Requires a Ph.D.

Qualifications

• Ph.D. in Toxicology, Pharmacology or related field required.
• 0–2 years of relevant experience in toxicology.
• Experience in safety assessments and risk characterization.
• Literature reviews and evidence synthesis experience.
• Strong writing and communication skills; ability to work independently.
• Able to obtain/maintain federal public trust clearance.

Responsibilities

• Conduct safety assessments and risk characterization of dietary ingredients and supplements.
• Review and evaluate NDIN submissions for regulatory review.
• Perform literature reviews and evaluate data quality.
• Integrate information from multiple sources to support conclusions.
• Conduct dose–response analyses and apply toxicological methods.
• Prepare technical memoranda, reports, and regulatory documents.
• Develop data gaps analyses and annotated bibliographies.
• Support ingredient prioritization and safety review activities.
• Present findings to reviewers and technical staff.
• Complete required training
• Utilize FDA databases and toxicology tools

Skills

Analytical thinking

Scientific writing

Independent work

Communication skills

Public trust clearance

Education

Ph.D. in Toxicology/Pharmacology or related field

Job description

Guidehouse is seeking 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 includes safety assessments, reviewing NDIN submissions, literature reviews, dose–response analyses, and preparing memoranda and regulatory documents.

Requires a Ph.D.