Director of Regulatory

Are you looking for an opportunity to shape the regulatory foundation of a purpose-driven company committed to advancing mental wellness worldwide? Seeking an experienced Director of Regulatory to offer significant strategic influence, global scope, and the chance to work on innovative products that make a meaningful impact on people’s lives.

The Director of Regulatory will serve as a trusted regulatory leader and strategic advisor, partnering closely with senior leadership and cross-functional teams across Product Development, Quality, Marketing, Legal, and Brand Partner Support. This role will shape regulatory strategy from concept through global commercialization, ensuring compliant, science-backed product launches across key international markets.

Responsibilities include:

• Lead and oversee all regulatory affairs functions, including U.S. compliance (FDA, FTC, DSHEA) and international regulatory requirements.
• Develop and execute regulatory strategies that support product innovation, brand positioning, and global market expansion.
• Review and approve product labels, packaging, marketing materials, and claims to ensure compliance with regulatory standards across all markets.
• Provide expert regulatory guidance to executive leadership, Product Development, Quality, Marketing, Legal, and Brand Partner support teams.
• Monitor global regulatory landscapes, anticipate changes, and proactively advise on potential impacts to existing and pipeline products.
• Lead international product registration efforts and compliance for key markets (e.g., Canada, EU, ASEAN, APAC), ensuring smooth product launches.
• Evaluate new ingredients, formulations, and claims for regulatory compliance and lead efforts to substantiate product claims scientifically.
• Oversee maintenance of comprehensive regulatory documentation to support audits, inspections, and regulatory submissions.

The Director of Regulatory will have:

• Bachelor’s degree in Regulatory Affairs, Nutrition, Food Science, Biology, or a related discipline; Master’s degree preferred.
• MUST have 8–12+ years of progressive regulatory affairs experience within dietary supplements, functional foods, or nutraceuticals.
• Deep knowledge of U.S. regulatory frameworks, including FDA regulations (21 CFR 111, 101, 117), FTC requirements, and DSHEA compliance.
• Demonstrated experience navigating international regulatory environments and leading global product registration initiatives.
• Strong strategic thinking, project management, and cross-functional leadership capabilities.

Preferred Qualifications

• RAC certification (U.S. or Global).
• Experience managing NDI notifications, GRAS submissions, or global regulatory submissions for dietary supplements.

•    Prior leadership experience in direct-selling, client-facing, or consultancy regulatory roles.
•    Experience in mental wellness, gut health, or functional nutrition product segments

For immediate consideration please resume outlining your related nutraceutical experience.