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 5× 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, TIME, Forbes, and Inc. as 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. 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 customer service messaging. Required Who You Are Minimum of 6 years experience in Regulatory Affairs in a GMP (Good Manufacturing Practices) environment, with at least 4 years executing technical regulatory reviews in dietary supplements for the U.S. Minimum B.Sc. in pharmaceutical, nutritional, or life sciences or a related scientific field. Experience in attaining and adhering to compliance with FDA regulations, including 21 CFR 111 and FSMA. Strong knowledge of the FDA regulatory landscape and enforcement discretion trends for dietary supplements. Experience with structure/function claim compliance and general FTC advertising rules. Strong knowledge of GMP product documentation requirements. Strong knowledge of dietary supplement labeling requirements. Experience representing regulatory positions in cross‑functional teams. Desired Experience working with live microbials / probiotic products, including manufacturing (CMC), analysis / methodologies, stability, taxonomy, delivery methods, mechanisms of action, and various health outcomes. Experience supporting GMP inspection documentation requests. Experience in international food supplement regulations, including EU, CAN (PLA and NPN registrations for Natural Health Products) and AUS, amongst other jurisdictions. Benefits + Perks Health & Wellness Choose from multiple medical, dental, and vision plans, with generous employer contributions and coverage options to meet your needs. Enjoy access to top‑tier virtual care and a complimentary Aaptiv membership for fitness and mental wellness. We also provide an HSA with employer contributions, along with Fullscript discounts for supplements. Mental Health Support All employees and eligible dependents receive 12 free therapy sessions per year, plus coaching, meditation, and 24/7 access to Spring Health’s digital tools and care navigation. Long Term Wealth Planning Invest in your future with our 401(k) plan through Betterment, featuring a 100% match on the first 3% and 50% on the next 2% of contributions—fully vested from day one. Supporting Families Our Parental Leave Policy includes 18 weeks of fully paid leave, with the flexibility to phase your return. We also offer four weeks of paid transition time at 80% capacity or four days per week. Time to Recharge Seed offers 15 vacation days, 7 sick/safe days, 2 personal days, 10 Recharge Days (Summer + Winter), and 15 paid company holidays each year. Work Flexibly Thrive in a remote‑first culture that prioritizes autonomy and clarity. You’ll also receive a $750 one‑time remote work setup stipend and ongoing access to a $450 quarterly wellness and workplace stipends via JOON. And More Access pet insurance, life and disability coverage, learning & development, and a vibrant culture rooted in science and impact. The annual pay range for this full‑time position is $130 k – $150 k plus equity and benefits across all U.S. locations (this position is 100% remote‑U.S.). Our pay ranges are guided by discipline, level and experience required. Within the range, individual pay may vary based on additional factors, including: your specific location, desired skills/technical competency, relevant experience and advanced education/training. Seed is an equal opportunity employer. For us, diversity isn’t an HR metric—it is the result of billions of years of evolution; it’s our nature. To serve our community inclusively means to cultivate a relative abundance of perspectives, backgrounds, geographies, and experiences. Like in biology, each role and its function is key to the productivity, sustainability, and resilience of our ecosystem. #J-18808-Ljbffr