Regulatory Compliance Reviewer

Regulatory Compliance Reviewer

locations

US - MD, Silver Spring

time type

Full time

posted on

Posted Yesterday

job requisition id

43752

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

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.