Regulatory Compliance Reviewer

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

Avantages offerts par ce poste

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

Paid Holidays

Parental Leave

Résumé du poste

Guidehouse is seeking a Scientist to evaluate dietary supplement labels for FDA compliance, review claims, and assess manufacturing CGMPs. You will analyze regulatory documentation and draft memoranda and letters as part of regulatory reviews.

Ideal candidates hold an MS or PhD in Nutrition, Food Science, Regulatory Science or related fields and have 0–2 years of relevant experience with labeling and FDA rules. On-site role with opportunities for growth.

Qualifications

• Experience evaluating food or dietary supplement labeling.
• Knowledge of FDA labeling regulations.

Responsabilités

• Evaluate dietary supplement labels for FDA compliance.
• Review notifications and determine regulatory compliance.
• Assess CGMP compliance and manufacturing processes.
• Draft regulatory memoranda and letters.

Connaissances

Regulatory writing

FDA labeling

Analytical skills

Formation

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

Description du poste

Job Family: Scientist Travel Required: Up to 10% Clearance Required: Ability to Obtain Public Trust

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.

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.
• 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.

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.

Guidehouse is a global AI-led professional services firm delivering advisory, technology, and managed services to the commercial and government sectors. With an integrated business technology approach, Guidehouse drives efficiency and resilience in the healthcare, financial services, energy, infrastructure, and national security markets. Built to help clients across industries outwit complexity, the firm brings together approximately 18,000 professionals to achieve lasting impact and shape a meaningful future. guidehouse.com