Regulatory Affairs Manager

Seed Health is a microbiome science company pioneering clinically validated innovations for gut and whole-body health.Our portfolio of gut-directed products is developed in collaboration with leading scientists and backed by human clinical research. We’re best known for DS-01® Daily Synbiotic—the #1 digestive health probiotic in the U.S.—trusted by millions of people for its benefits in and beyond the gut, including skin, immune, and heart health.We’ve since expanded our offerings to include PDS-08® for pediatric health, VS-01™ for vaginal health, and a new category of Co-Biotics for daily nutrition, energy, and sleep—each grounded in our commitment to scientific rigor, precision formulation, and impact across the body’s interconnected systems. Beyond the body, SeedLabs—our environmental research division—advances microbial solutions that restore biodiversity and support ecosystems affected by human activity.We’ve built a profitable DTC business with category-leading retention, grown revenue 5x in the last 36 months, and expanded our reach across new channels and markets. With a robust clinical pipeline and continued expansion into new areas of microbiome health, we’re building for scale—with integrity, care, and curiosity.Our work has been recognized by Fast Company (Most Innovative Companies, Brands That Matter, World Changing Ideas), TIME (Best Inventions), Forbes (America’s Best Startup Employers), and Inc. (Best in Business, Female Founder 100)—a reflection of the science behind our products and the stories we tell to bring them into the world.We’re a galaxy-class team of researchers, clinicians, designers, engineers, storytellers, and builders—each aligned in our belief in the transformative potential of the microbiome. If you’re a kindred dot-connector looking to shape the future of health, join us.seedhealth.com • seed.com • luca.bioYouAs a Regulatory Affairs Manager, you'll support the execution of our content and compliance processes, helping ensure they reach their fullest expression while upholding Seed's reputation for scientific integrity. Working closely with the Director of Regulatory Affairs, you'll collaborate across teams to flag risks, provide regulatory guidance, and keep day-to-day compliance activities moving in a complex and fast-changing landscape.As Regulatory Affairs Manager, you'll contribute to Seed's global regulatory and compliance strategy by owning key workstreams across labeling, claims substantiation, ingredient documentation, and product review. You'll partner cross-functionally to support product development and brand initiatives — translating regulatory requirements into clear, actionable guidance for the teams around you.This role is well-suited for someone with solid experience navigating regulatory gray areas in the dietary supplement space — a detail-oriented, thoughtful professional who knows when to escalate and when to execute. You'll play an important role in protecting Seed's reputation, ensuring our science and messaging are both compelling and compliant.What You’ll Do:Execute Core Regulatory & Compliance Reviews: Conduct ingredient, formula, and packaging compliance reviews in accordance with applicable regulatory frameworks, particularly the U.S. FDCA, including DSHEA, 21 CFR 184, GRAS, SCOGS, and 21 CFR 111. Conduct label artwork and asset compliance reviews and execution according to internal SOPs and FDCA labeling requirements.Generate and Maintain Regulatory Documentation: Maintain raw material and formula-level compliance documentation, including ingredient status (GRAS, ODI, NDIN), allergen declarations, and Proposition 65 requirements. Claims Compliance: Execute compliance reviews consistent with FTC and FDA claims compliance standards and product substantiation. Coordinate Regulatory Feedback to Cross-Functional Teams: Serve as day-to-day regulatory contact for Brand, Creative, and Marketing on regulatory review deliverables. Triage incoming review requests across multiple systems (e.g., Asana, Slack, QMS), set timelines, and manage throughput across competing priorities. Provide consistent, actionable feedback with compliant pathways forward. Support Process Development & Optimization: Partner with the Director of Regulatory Affairs and Quality Department to develop and implement SOPs for regulatory review processes and documentation standards. Work with emerging technologies to develop automations that streamline workflows. Collaborate with cross-functional partners to improve ways of working. Support GMP Compliance: Support audit readiness by contributing to, reviewing and approving QMS records, particularly labels, formulas, specifications, change controls, and investigations. Identify process and compliance gaps and propose solutions. Support Operational Optimization with Emerging Technologies: Integrate RA into generative AI workflows to ensure all outputs are compliant. Collaborate with Member Experience: Maintain consumer-relevant, accurate c