Principal Regulatory Consultant

Job Title: Principal Regulatory Consultant Dietary Supplements (U.S.-Based)

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)