Regulatory Food Senior Scientist

Guidehouse•Silver Spring, MD

21d•$171,000 - $285,000

About The Position

Lead proactive surveillance and safety assessment of self-determined Generally Recognized as Safe (GRAS) food ingredients in anticipation of a transition to a mandatory pre-market GRAS regulatory process. Develop and implement reproducible methodologies for surveying publicly available information to identify substances claimed as self-GRAS, including trade press and public announcements. Build and maintain a comprehensive database of self-GRAS substances, documenting market presence, supporting evidence, safety information, and relevant regulatory records. Prepare detailed surveillance methodology and findings reports suitable for publication in peer-reviewed scientific journals. Evaluate and prioritize substances currently on the U.S. market for public health relevance, justifying prioritization decisions in formal reports. Conduct safety assessments of high-priority substances, synthesizing information from regulatory authorities (e.g., JECFA, EFSA, Health Canada), scientific literature, adverse event reports, and historical consumption data. Draft public health risk reports and safety assessments to support FDA risk communication and compliance efforts. Collaborate with FDA staff and other contractors to ensure sound judgment in prioritization and safety assessment decisions. Present methodology, database, and findings to the FDA at key milestones, both virtually and in-person at the College Park, MD campus. Ensure all deliverables and electronic content meet Section 508 accessibility standards.

Requirements

A PhD in Toxicology, Pharmacology, Chemistry, Food Science, or a closely related field is required
A Minimum of TEN (10) years of experience
U.S. citizenship or legal authorization to work for the FDA is required
Extensive experience in food ingredient safety assessment, toxicological risk evaluation, and regulatory compliance (FDA, GRAS, food additives).
Demonstrated ability to conduct literature reviews, analyze scientific data, and synthesize findings for publication.
Experience with regulatory submissions, risk prioritization, and public health risk reporting.
Strong project management and technical writing skills, with a track record of producing peer-reviewed publications.
Proficiency in database development and management (e.g., SharePoint, Excel).
Ability to work collaboratively with multidisciplinary teams and communicate complex scientific concepts to diverse audiences.

Nice To Haves

Prior experience supporting FDA, USDA, or other regulatory agencies on GRAS or food additive safety projects.
Familiarity with international food safety standards and regulatory authorities (JECFA, EFSA, Health Canada, FSANZ).
Experience with social media listening and alternative data sources for safety surveillance.
Knowledge of Section 508 compliance and electronic content accessibility standards.
Experience presenting scientific findings to regulatory agencies and at professional conferences.
Advanced skills in data analysis tools (e.g., PubMed, Google Scholar, statistical software).
Experience with FDA’s Food Applications Regulatory Management (FARM) System and the FDA network resources.

Responsibilities

Lead proactive surveillance and safety assessment of self-determined Generally Recognized as Safe (GRAS) food ingredients
Develop and implement reproducible methodologies for surveying publicly available information to identify substances claimed as self-GRAS
Build and maintain a comprehensive database of self-GRAS substances
Prepare detailed surveillance methodology and findings reports suitable for publication in peer-reviewed scientific journals
Evaluate and prioritize substances currently on the U.S. market for public health relevance
Conduct safety assessments of high-priority substances
Draft public health risk reports and safety assessments to support FDA risk communication and compliance efforts
Collaborate with FDA staff and other contractors
Present methodology, database, and findings to the FDA at key milestones
Ensure all deliverables and electronic content meet Section 508 accessibility standards

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