Principal Regulatory Consultant Dietary Supplements - Jobs via Dice : Job Details

Principal Regulatory Consultant Dietary Supplements

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Job Description:

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

Position Type: Contract / Consulting

Location: Jersey City, NJ

Department: Regulatory Affairs / Corporate Development

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:

• 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.
• 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.
• Regulatory Compliance Evaluation
• Assess target company's compliance with DSHEA, FDA 21 CFR Part 111 cGMPs, and labeling requirements.
• Evaluate quality systems, manufacturing records, and product release protocols.
• Review internal audit procedures, CAPA systems, and regulatory training programs.
• Labeling, Claims, and Marketing Compliance
• Conduct audits of product labels and marketing materials for structure/function claims, health claims, nutrient content claims, and compliance with FTC standards.
• Advise on corrective actions for non-compliance.
• Ingredient and Formulation Review
• Evaluate regulatory status of ingredients, including NDI notifications, GRAS determinations, and documentation of ingredient history.
• Review formulation dossiers, technical specifications, and supplier qualification records.
• Post-Acquisition Integration Support
• Develop regulatory integration plans, advise on remediation strategies, and support harmonization of SOPs and labeling standards.

Qualifications:

Education: Advanced degree (MS, PhD, PharmD, JD) in Regulatory Affairs, Pharmaceutical Sciences, Nutrition, Public Health, or related discipline.

Experience: Minimum 10-15 years in U.S. dietary supplement regulatory affairs, with at least 5 years in M&A due diligence or regulatory audits. Experience with contract manufacturers, private equity, brand owners, and regulatory agencies is required.

Certifications (Preferred): RAC, CQA, CDSP

Technical Competencies: Expert knowledge of DSHEA, FDA 21 CFR Parts 111 & 101, NDI process, GRAS, FDA Labeling, FTC advertising standards, FDA warning letter trends, FDA portals, and regulatory intelligence tools.

Soft Skills: Analytical skills, strong communication, ability to manage multiple projects, high attention to detail, collaborative mindset.

About Us: Apptad offers strategic consulting, enterprise information management, and digital transformation services. With offices in the US and India, Apptad focuses on innovative data solutions, customer-centric approaches, and ethical practices.

Our Mission: Customer focus, innovation, accountability, and ethics.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Legal

Industries

• Software Development

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