• Job Description

  Req#: 37662
  Job Description: Job Title: Principal Regulatory Consultant - Dietary Supplements (U.S.-Based)
  Position Type: Contract / Consulting
  Location: U.S.-based
  Department: Regulatory Affairs / Corporate Development
  Reports To: Head/Director of Regulatory Affairs & Strategy
  Position Summary:
  We are seeking a highly experienced and credentialed Regulatory Consultant to support
  strategic M&A due diligence initiatives within the dietary supplement industry. This role demands
  a deep understanding of the U.S. regulatory landscape, including DSHEA, FDA cGMPs (21 CFR Part
  111), NDI notifications, GRAS determinations, and labeling and marketing compliance. The
  consultant will play a critical role in evaluating regulatory risk, identifying compliance gaps, and
  advising on integration strategies for target companies.
  Core Responsibilities:
  A. M&A Due Diligence & Strategic Advisory
  • Lead comprehensive regulatory due diligence for potential acquisitions, including:
  • Review of regulatory history, warning letters, recalls, and enforcement actions.
  • Analysis of compliance documentation, SOPs, and audit reports.
  • Identification of regulatory liabilities, red flags, and integration risks.
  • Prepare detailed regulatory risk assessment reports for executive and legal teams.
  • Participate in cross-functional diligence meetings and provide expert insights on regulatory
  implications.
  B. Regulatory Compliance Evaluation
  • Assess target company's compliance with:
  • Dietary Supplement Health and Education Act (DSHEA)
  • FDA 21 CFR Part 111 - Current Good Manufacturing Practices (cGMPs)
  • FDA 21 CFR Part 101 - Labeling requirements
  • Evaluate quality systems, manufacturing records, and product release protocols.
  • Review internal audit procedures, CAPA systems, and regulatory training programs.
  C. Labeling, Claims, and Marketing Compliance
  • Conduct in-depth audits of product labels and marketing materials for:
  • Structure/function claims
  • Health claims and nutrient content claims
  • Supplement Facts panel accuracy
  • Required disclaimers and font/format compliance
  • Assess compliance with FTC advertising standards, including digital and influencer marketing.
  • Advise on corrective actions for non-compliant claims and promotional practices.
  D. Ingredient and Formulation Review
  • Evaluate regulatory status of ingredients, including:
  • New Dietary Ingredient (NDI) notifications - completeness, safety data, and FDA
  response history.
  • GRAS determinations - self-affirmed vs. FDA-reviewed.
  • Legacy ingredients and their historical use documentation.
  • Review formulation dossiers, technical specifications, and supplier qualification records.
  E. Post-Acquisition Integration Support
  • Develop regulatory integration plans for acquired entities.
  • Advise on remediation strategies for identified compliance gaps.
  • Support harmonization of SOPs, labeling standards, and quality systems across entities.
  • Provide training and onboarding for regulatory teams post-acquisition.
  Qualifications:
  Education:
  • Advanced degree (MS, PhD, PharmD, JD) in Regulatory Affairs, Pharmaceutical
  Sciences, Nutrition, Public Health, or related discipline.
  Experience:
  • Minimum 10-15 years of experience in U.S. dietary supplement regulatory affairs.
  • At least 5 years of direct involvement in M&A due diligence or regulatory audits.
  • Experience working with contract manufacturers, private equity firms, brand owners,
  and regulatory agencies.
  Certifications (Preferred):
  • RAC (Regulatory Affairs Certification)
  • Certified Quality Auditor (CQA)
  • Certified Dietary Supplement Professional (CDSP)
  Technical Competencies:
  • Expert-level knowledge of:
  • DSHEA, FDA 21 CFR Parts 111 & 101
  • NDI notification process, GRAS submissions
  • FDA Labeling Guidance, FTC Advertising Guidelines
  • Familiarity with:
  • FDA Warning Letter trends
  • eCTD submissions, FDA portals
  • Regulatory intelligence tools
  Soft Skills & Attributes:
  • Exceptional analytical and critical thinking skills.
  • Strong written and verbal communication abilities.
  • Ability to work independently and manage multiple concurrent projects.
  • High attention to detail and commitment to regulatory integrity.
  • Collaborative mindset with cross-functional teams (legal, quality, operations)
  Additional Sills:

• About the company

  The best remote jobs for you

Notice