Director of Regulatory Affairs

Momentous•Park City, UT

1d•Hybrid

About The Position

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.

Requirements

10+ years of experience in regulatory affairs within dietary supplements, food, pharmaceuticals, or consumer health products, with at least 5 years in a senior or leadership capacity.
Deep working knowledge of DSHEA, FDA labeling regulations (21 CFR 101, 111), FTC advertising guidance, and NDI notification processes.
Demonstrated experience reviewing and approving product claims, labels, and marketing content for regulatory compliance.
Experience working directly with FDA, state regulators, or through FDA inspections/audits.
Strong cross-functional communication skills — able to translate regulatory requirements into clear guidance for non-regulatory teams (Marketing, Product, Ecommerce).
Bachelor's degree in a related scientific, legal, or regulatory field; JD, advanced regulatory certification (RAC), or relevant graduate degree a plus.

Nice To Haves

Direct experience in sports nutrition, performance supplements, or NSF Certified for Sport / Informed Sport certification processes.
Experience supporting international market expansion and cross-border regulatory compliance.
Familiarity with contract manufacturing relationships and GMP audit processes.
Prior experience at a high-growth consumer brand balancing compliance rigor with commercial speed.

Responsibilities

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.
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.
Partner with Quality and contract manufacturers/co-packers to ensure GMP compliance (21 CFR Part 111) across the supply chain.
Support audit readiness for FDA inspections, NSF/Informed Sport certifications, and third-party quality audits.
Review Certificates of Analysis, supplier documentation, and specification sheets for regulatory adequacy (an area directly relevant to Momentous's ingredient sourcing and finished-product specs) including but not limited to TLA, MSSA, and other supplier contracts.
Serve as the regulatory voice in Innovation Phase Gate reviews, flagging risk and required documentation early in the product development cycle.
Train and enable Marketing, Retail, Ecommerce, and Customer Experience teams on regulatory guardrails so they can operate confidently within compliant boundaries.
Act as primary liaison with outside regulatory counsel, testing labs (e.g., Eurofins, NSF), and industry bodies (e.g., CRN, AHPA) on matters affecting Momentous's category.
Monitor competitor and industry regulatory actions (warning letters, FTC settlements, recalls) for relevant lessons and risk signals.
Assess regulatory requirements for new international markets (e.g., Canada's NHP framework, EU Regulation 1169/2011, Australia/New Zealand Food Standards Code) as Momentous expands distribution.
Coordinate labeling and claims adaptation for cross-border sales, including allergen labeling differences already relevant to Momentous's fish oil and other allergen-containing products.