Regulatory Compliance Reviewer
Guidehouse•Silver Spring, MD
•$65,000 - $108,000•Remote
About The Position
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.
Requirements
- 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
Nice To Haves
- 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
Responsibilities
- 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
