Regulatory Affairs Director, Supplements & Global Compliance

Momentous; Utah; Hybrid; USD 180,000 - 230,000; Full time

Benefits offered by this job

Health/Vision/Dental

401k Match

Unlimited PTO

Finish Line Fridays

Employee stock options

Job summary

Momentous seeks a Director of Regulatory Affairs to lead global regulatory strategy and compliance for its dietary supplement portfolio. This pivotal role oversees labeling, claims substantiation, and manufacturing compliance across markets, partnering with Marketing, Science, Legal, and Operations.

The ideal candidate brings extensive DSHEA knowledge, leadership experience, and a track record of navigating FDA inspections and international regulations.

Qualifications

• 10+ years regulatory affairs in dietary supplements, food, pharma, or consumer health products.
• At least 5 years in a senior or leadership capacity.
• Deep working knowledge of DSHEA, FDA labeling regulations (21 CFR 101,111), and FTC guidance.
• Experience reviewing/approving product claims, labels, and marketing content for regulatory compliance.
• Experience working with FDA/state regulators or through inspections/audits.

Responsibilities

• Regulatory Strategy & Compliance: Own strategy across all markets, develop regulatory framework, lead due diligence for launches and expansions.
• Label & Claims Review: Approve labels and packaging, review claims for substantiation, maintain substantiation files.
• Manufacturing & Quality Compliance: Partner with QA and contract manufacturers to ensure GMP compliance; support audits.
• Cross-Functional Partnership: Serve as regulatory voice in reviews; train teams; liaison with outside counsel, labs and industry bodies.
• International Expansion Support: Assess requirements for new markets; coordinate labeling/claims for cross-border sales.

Skills

Regulatory strategy

FDA regulations

NDI/GRAS

GMP compliance

Cross-functional leadership

Regulatory liaison

Education

Bachelor's degree in science/regulatory

JD or RAC (preferred)

Job description

Momentous seeks a Director of Regulatory Affairs to lead global regulatory strategy and compliance for its dietary supplement portfolio. This pivotal role oversees labeling, claims substantiation, and manufacturing compliance across markets, partnering with Marketing, Science, Legal, and Operations.

The ideal candidate brings extensive DSHEA knowledge, leadership experience, and a track record of navigating FDA inspections and international regulations.