Regulatory Compliance Reviewer

Guidehouse; 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

Paid Holidays and Sick Time

Parental Leave

Tuition Reimbursement and Learning

Job summary

Guidehouse is seeking a Regulatory Compliance Subject Matter Expert to evaluate dietary supplement labels, CGMP compliance, and structure/function claims for regulatory alignment. The role supports regulatory decision-making through technical analysis, market surveillance, and preparation of scientific and regulatory documentation.

You will utilize FDA databases and related tools, draft memoranda and letters, and ensure compliance with federal dietary supplement regulations.

Qualifications

• Must have MS or PhD in Nutrition, Food Science, Regulatory Science, Public Health, or related discipline.
• 0–2 years of relevant experience preferred.
• Knowledge of FDA labeling regulations and dietary supplement CGMP requirements.
• Strong analytical, technical writing and communication skills.
• Experience preparing regulatory review documentation and regulatory correspondence.

Responsibilities

• Evaluate dietary supplement labels for compliance with FDA regulations.
• Review structure/function claim notifications for compliance.
• Assess manufacturing processes for CGMP compliance.
• Conduct market surveillance to identify regulatory violations.
• Prepare regulatory review memoranda and warning letter language as needed.
• Review applicable statutes, regulations and guidance documents; use FDA databases for support.
• Draft scientific memoranda and regulatory correspondence.
• Support issuance of dietary supplement export certificates.

Skills

Analytical skills

Regulatory writing

FDA labeling knowledge

Communication skills

Regulatory knowledge

Education

MS or PhD in Nutrition, Food Science, Regulatory Science, Public Health, or related discipline

Tools

FDA databases

Web-based analytical tools

Job description

Job Family:ScientistTravel Required:Up to 10%Clearance Required:Ability to Obtain Public TrustOur federal client is responsible for protecting public health through regulatory oversight of food labeling and manufacturing activities. Guidehouse is seeking experienced Regulatory Compliance Subject Matter Expert to evaluate product labels, manufacturing processes, structure/function claims, and compliance with dietary supplement regulations and current Good Manufacturing Practice (CGMP) requirements. The role supports regulatory decision-making through technical analysis, market surveillance, and preparation of scientific and regulatory documentation.What You Will Do:Evaluate dietary supplement labels for compliance with applicable FDA regulations.Review structure/function claim notifications and determine regulatory compliance.Assess manufacturing processes for compliance with dietary supplement CGMP requirements.Conduct market surveillance activities to identify potential regulatory violations.Analyze inspection findings and prepare regulatory review memoranda.Support issuance of dietary supplement export certificates.Draft scientific memoranda, regulatory correspondence, objection letters, and warning letter language as appropriate.Review and apply applicable statutes, regulations, guidance documents, and scientific literature.Utilize FDA databases and web-based analytical tools to support review activities.Complete all required corporate, client, safety, security, and laboratory training requirements.What You Will Need:M.S. or Ph.D. in Nutrition, Food Science, Regulatory Science, Public Health, or related discipline.Minimum ZERO - TWO (0-2) years of prior relevant experienceExperience evaluating food or dietary supplement labeling.Knowledge of FDA food labeling regulations.Knowledge of dietary supplement CGMP requirements.Strong analytical, technical writing, and communication skills.Experience preparing regulatory review documentation.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 preferredWhat Would Be Nice To Have:Experience supporting FDA, USDA, CDC, public health, food safety, or other regulatory programs.Dietary supplement regulatory review experience.Experience reviewing Structure Function Claim Notifications (SFCNs).Experience conducting market surveillance activities.Familiarity with FDA databases and internal review systems.Experience supporting manufacturing compliance reviews and warning letter developmentThe 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: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 InsurancePersonal and Family Sick Time & Company Paid HolidaysParental Leave401(k) Retirement PlanGroup Term Life and Travel AssistanceVoluntary Life and AD&D InsuranceHealth Savings Account, Health Care & Dependent Care Flexible Spending AccountsTransit and Parking Commuter BenefitsShort-Term & Long-Term DisabilityTuition Reimbursement, Personal Development, Certifications & Learning OpportunitiesEmployee Referral ProgramCorporate Sponsored Events & Community OutreachCare.com annual membershipEmployee Assistance ProgramSupplemental 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 bonusAbout GuidehouseGuidehouse 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 [e-mail]. 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 [e-mail]. 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 [e-mail]. 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.