Director of Regulatory Affairs

Company Overview:

Momentous is a dynamic, fast-growing human performance company offering the highest quality supplements designed to enhance physical and cognitive well-being. At Momentous, we believe that people at their best will produce a positive impact in their personal lives, communities, and, ultimately, the world. No matter our customer's goal or what they want to achieve, we are on a relentless quest to help them get there.

We work with some of the greatest minds in science and athletic performance who tap into the latest research and real-world experience to create a portfolio of products designed with one common goal—to help our customers be their best.

• Best in the field.We have built an advanced network of world-renowned experts in the field of human performance.
• Trusted and used by the best.We are honored to work with more than 150 teams in professional and NCAA sports, including Stanley Cup Champions, Tour de France winners, and allNFL Teams.
• Push what’s possible.Named to the prestigious Inc. 5000 list three years in a row (#392 in 2025) as one of the fastest-growing companies in the US. Ranked #4 in the Rocky Mountain Region in 2025.

Reporting into the VP of Innovation, the Director of Regulatory Affairs is responsible for ensuring that Momentous's entire product portfolio — formulations, labels, marketing claims, and manufacturing practices — complies with FDA, FTC, USDA (where applicable), and international regulatory requirements across all markets where Momentous sells.

This role is the company's primary regulatory authority: setting the standards that Product, Applied Science, Marketing, and Operations build against, evaluating new ingredients and formulations for regulatory viability before they reach commercialization, and serving as Momentous's point of contact for regulatory bodies, co-manufacturers, and legal counsel on compliance matters. The ideal candidate combines deep expertise in dietary supplement law (DSHEA, NDI notifications, GMP) with the judgment to balance rigorous compliance against the pace of a fast-growing consumer brand.

Regulatory Strategy & Compliance

• Own Momentous's regulatory compliance strategy across all product categories and all markets (U.S., and international markets as the company expands).
• Evaluate new ingredients, formulations, and delivery formats for regulatory viability early in development — including NDI (New Dietary Ingredient) status, GRAS considerations, and any FDA warning letters or import alerts relevant to a given ingredient.
• Maintain and continuously update Momentous's regulatory framework as FDA, FTC, and state-level guidance evolves (e.g., NDI reform, state-level supplement restrictions, international market access rules).
• Lead regulatory due diligence for new product launches, formulation changes, and market expansions.

Label & Claims Review

• Review and approve all product labels, packaging, and inserts for compliance with FDA labeling regulations (21 CFR Part 101), including nutrient content claims, structure/function claims, and required disclosures.
• Partner with Science Integration, Marketing, and Legal to review consumer-facing claims (website, packaging, advertising, influencer/affiliate content) for substantiation and FTC compliance prior to publication.
• Maintain claims substantiation files for all structure/function and health-related claims across the portfolio.
• Advise on acceptable claims language for new product launches and campaigns, flagging risk before content goes live rather than after.

Manufacturing & Quality Compliance

• Partner with Quality and contract manufacturers/co-packers to ensure GMP compliance (21 CFR Part 111) across the supply chain.
• Support audit…