Regulatory Compliance Reviewer

Guidehouse Inc.; Silver Spring (MD); Sur place; USD 65 000 - 108 000; Plein temps

Avantages offerts par ce poste

Medical, Rx, Dental & Vision Insurance

401(k) Retirement Plan

Group Term Life and Travel Assistance

Health Savings Account, Health Care &D

Transit and Parking Commuter Benefits

Tuition Reimbursement, PersonalDev,Lic

Employee Referral Program

Care.com annual membership

Employee Assistance Program

Supplemental Benefits via Corestream

Résumé du poste

Guidehouse Inc. is seeking a Regulatory Compliance Subject Matter Expert to evaluate dietary supplement labels, manufacturing processes, and claims for FDA compliance and CGMP adherence. The role supports regulatory decision-making through technical analyses and regulatory documentation.

The ideal candidate has an advanced degree and up to 2 years of relevant experience, with strong writing and communication skills. A federal/public trust eligibility is required or pursued.

Qualifications

• MS/PhD in Nutrition, Food Science, Regulatory Science, Public Health, or related field.
• Experience evaluating food or dietary supplement labeling and FDA regulations.
• Strong analytical, technical writing, and communication skills.

Responsabilités

• Evaluate dietary supplement labels for FDA regulatory compliance.
• Review structure/function claim notifications for compliance.
• Assess CGMP compliance in manufacturing processes for supplements.
• Conduct market surveillance to identify regulatory violations.
• Analyze inspection findings and draft regulatory memoranda.
• Support issuance of dietary supplement export certificates.
• Draft regulatory letters and correspondence as needed.
• Review statutes, regulations, and guidance documents.
• Use FDA databases and tools to support reviews.

Connaissances

FDA labeling regulations

Regulatory submissions

CGMP for dietary supplements

Technical writing

Data analysis

Formation

MS or Ph.D. in Nutrition, Food Science, Regulatory Science, Public Health, or related discipline

Outils

FDA databases

Web-based analytical tools

Internal review systems

Description du poste

Job Family :

Scientist

Travel Required :

Up to 10%

Clearance Required :

Ability to Obtain Public Trust

Our 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 experience
• Experience 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 preferred

What 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 development

The 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:

• 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 [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 re