Regulatory Food Senior Scientist

Job Family :

IT Project Management

Travel Required :

Up to 25%

Clearance Required :

Ability to Obtain Public Trust

What You Will Do:

• 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.

What You Will Need:

• 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.

What Would Be Nice To Have:

• 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.

The annual salary range for this position is $171000.00-$285000.00. 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:

Guidehouse offers a comprehensive total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

• 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.

If you have visited our website for information about employment opportunities or to apply for a position and you require an accommodation please contact Guidehouse Recruiting at 1-571-633-1711 or via email at [email protected] . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or [email protected] .  Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse.  Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.

If any person or organization demands money related to a job opportunity with Guidehouse please report the matter to Guidehouse’s Ethics Hotline. If you want to check the validity of correspondence you have received please contact [email protected] . Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant’s dealings with unauthorized third parties.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.