Regulatory Affairs Manager

Responsibilities

• Conduct ingredient, formula, and packaging compliance reviews in accordance with U.S. FDCA, DSHEA, 21 CFR 184, GRAS, SCOGS, and 21 CFR 111
• Maintain raw material and formula-level compliance documentation, including allergen declarations and Proposition 65 requirements
• Execute compliance reviews consistent with FTC and FDA claims compliance standards
• Serve as the day-to-day regulatory contact for Brand, Creative, and Marketing teams
• Partner with the Director of Regulatory Affairs to develop and implement SOPs for regulatory review processes
• Support GMP compliance and audit readiness by reviewing QMS records, labels, and formulas
• Integrate regulatory affairs into generative AI workflows to ensure compliant outputs

Requirements

• Minimum of 6 years experience in Regulatory Affairs in a GMP environment
• At least 4 years executing technical regulatory reviews in dietary supplements for the U.S.
• B.Sc. in pharmaceutical, nutritional, life sciences, or a related scientific field
• Experience with FDA regulations including 21 CFR 111 and FSMA
• Strong knowledge of FDA regulatory landscape and enforcement discretion for dietary supplements
• Experience with structure/function claim compliance and FTC advertising rules
• Strong knowledge of GMP product documentation and dietary supplement labeling requirements

Preferred Qualifications

• Experience working with live microbials or probiotic products (CMC, stability, taxonomy)
• Experience supporting GMP inspection documentation requests
• Experience with international food supplement regulations (EU, Canada, Australia)

About the Company

Seed Health is a microbiome science company pioneering clinically validated innovations for gut and whole-body health. We are a science-driven DTC business focused on precision formulation and microbial solutions for human and environmental health.