Position Overview
The Director of Compliance & Regulatory Affairs will define and lead the organization’s global regulatory strategy, ensuring all nutraceutical and botanical products meet the highest standards of safety, quality, and legal compliance. This leader will architect compliance frameworks, oversee regulatory submissions, and guide cross-functional teams to ensure product integrity across the full lifecycle.
The role serves as the primary regulatory authority internally — shaping policy, managing audits, and maintaining strong relationships with regulatory bodies and industry partners worldwide.
Key Responsibilities
Regulatory Strategy & Oversight
Develop and execute regulatory strategies for nutraceutical and botanical products across key global markets (U.S., EU, Asia, LATAM, etc.).
Continuously monitor evolving regulations (FDA, EFSA, Health Canada, ASEAN, etc.) and proactively update company policies.
Ensure adherence to GMP, accurate labeling, compliant claims, and substantiated scientific positioning.
Compliance Program Leadership
Build, maintain, and improve company-wide compliance systems spanning product development, manufacturing, marketing, and distribution.
Conduct internal audits, gap analyses, and risk assessments; implement corrective and preventive actions (CAPA).
Oversee documentation, QMS controls, SOPs, and audit readiness for regulatory inspections and third-party certifications.
Regulatory Submissions & Product Approvals
Lead preparation and submission of dossiers, notifications, and registrations for dietary supplements, botanicals, and functional ingredients.
Serve as the regulatory point of contact with authorities to facilitate approvals and resolve issues.
Ensure all product labeling, packaging, and consumer-facing claims meet global regulatory standards and are supported by scientific evidence.
Cross-Functional Partnership
Collaborate closely with R&D, Quality, Supply Chain, Marketing, and Legal to ensure compliance throughout concept development, formulation, production, and commercialization.
Provide ongoing regulatory training and support across the organization.
Represent the company in industry associations, scientific committees, and regulatory working groups.
Risk & Ethical Governance
Establish policies to mitigate regulatory, reputational, and operational risks.
Ensure ethical marketing practices, responsible communication, and transparent consumer claims.
Stay ahead of emerging compliance considerations, including sustainability, biodiversity protection, and ethical ingredient sourcing.
Qualifications
Advanced degree in Regulatory Affairs, Pharmaceutical Sciences, Food Science, or a related scientific discipline.
10+ years of regulatory and compliance leadership experience within nutraceuticals, botanicals, dietary supplements, or related sectors.
Extensive knowledge of FDA, FTC, EFSA, and international regulatory ecosystems.
Proven success managing regulatory submissions, inspections, and external audits.
Exceptional leadership, communication, and cross-functional influencing skills.
Desired Competencies
Expertise in global botanical regulations (novel food assessments, traditional herbal medicine frameworks, plant-based therapeutic standards).
Familiarity with international trade, import/export, and ingredient sourcing compliance.
Strong ability to interpret scientific data and translate it into compliant product claims and regulatory positions.
Strategic thinker capable of both high-level planning and hands-on implementation.
Unwavering commitment to ethics, consumer safety, and scientific integrity.
Performance Metrics
On-time, successful regulatory approvals and market entry.
Zero major compliance violations in audits or inspections.
Strong implementation of proactive risk mitigation strategies.
High-quality cross-functional compliance alignment and training outcomes.
Contribution to the company’s reputation as a trusted, science-driven leader in the nutraceutical space.