Regulatory Consultant M&A Due Diligence

Regulatory Consultant M&A Due Diligence

Posted 2 weeks ago by 1752563643

Apply
Negotiable
Outside
Remote
USA
Apply
Acquisition Due Diligence Advertisement Due Diligence Equity and Debt External Auditing Influencer Marketing Internal Auditing Marketing Materials Mergers And Acquisitions Private Equity

Summary: The Regulatory Consultant for M&A Due Diligence in the dietary supplement industry will provide expert guidance on regulatory compliance and risk assessment during strategic mergers and acquisitions. This role requires extensive knowledge of U.S. regulations, including DSHEA and FDA guidelines, to evaluate potential acquisitions and ensure compliance. The consultant will also support post-acquisition integration and advise on regulatory strategies for target companies. Strong analytical skills and experience in regulatory affairs are essential for success in this position.

Key Responsibilities:

  • Lead comprehensive regulatory due diligence for potential acquisitions, including review of regulatory history, warning letters, recalls, and enforcement actions.
  • Analyze compliance documentation, SOPs, and audit reports.
  • Identify 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.
  • Assess target company’s compliance with DSHEA, FDA cGMPs, and labeling requirements.
  • Evaluate quality systems, manufacturing records, and product release protocols.
  • Review internal audit procedures, CAPA systems, and regulatory training programs.
  • Conduct in-depth audits of product labels and marketing materials for compliance with claims and FTC advertising standards.
  • Evaluate regulatory status of ingredients, including NDI notifications and GRAS determinations.
  • Develop regulatory integration plans for acquired entities and advise on remediation strategies for compliance gaps.
  • Provide training and onboarding for regulatory teams post-acquisition.

Key Skills:

  • Advanced degree (MS, PhD, PharmD, JD) in Regulatory Affairs, Pharmaceutical Sciences, Nutrition, Public Health, or related discipline.
  • 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.
  • Preferred certifications: RAC, CQA, CDSP.
  • Expert-level knowledge of DSHEA, FDA 21 CFR Parts 111 & 101, NDI notification process, and GRAS submissions.
  • Exceptional analytical and critical thinking skills.
  • Strong written and verbal communication abilities.
  • Ability to work independently and manage multiple concurrent projects.
  • Collaborative mindset with cross-functional teams.

Salary (Rate): undetermined

City: undetermined

Country: USA

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:

Job Title: Regulatory Consultant M&A Due Diligence (Dietary Supplement Industry)

Location: Remote

Duration: 12+ Months

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:

  1. 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.

  1. 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.
  1. 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.
  1. 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.
  1. 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)
Apply
Similar Jobs
Loading data...