Dietary Supplements CGMP Compliance Scientist

Guidehouse Inc.

Silver Spring (MD)

On-site

USD 65,000 - 108,000

Full time

4 days ago
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Benefits offered by this job

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

Job summary

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.

Responsibilities

  • 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.

Skills

FDA labeling regulations
Regulatory submissions
CGMP for dietary supplements
Technical writing
Data analysis

Education

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

Tools

FDA databases
Web-based analytical tools
Internal review systems

Job description

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.

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