Principal Regulatory Consultant /Manager (US Based Dietary Supplements)

Job Description :

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.

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).