Jobs · Legal

Regulatory Affairs Manager

Seed Health · United States · 4 wk ago
RemoteRemoteLegal$130k–$150k/yrFull-time

You

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.

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.
  • Career Development: Support process development and optimization by partnering 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.

Who You Are

  • Required:
  • - Minimum of 6 years experience in Regulatory Affairs in a GMP (Good Manufacturing Practices) environment, with at least 4 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.

Annual Pay Range

The annual pay range for this full-time position is $130k-$150k + equity + benefits across all US locations (this position is 100% remote-US).

Benefits

  • Medical, Dental, Vision
  • Life, AD&D, LTD
  • Mental Wellness, EAP, Wellness Stipend
  • 401(k) match

Work Flexibly

  • Remote-first culture
  • $750 one-time remote work setup stipend
  • Ongoing access to a $450 quarterly wellness and workplace stipends via JOON

Additional Benefits

  • Pet insurance
  • Life and disability coverage
  • Learning & development
  • Vibrant culture rooted in science and impact

About Seed Health

We are 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.

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.

Similar jobs

Regulatory Affairs Manager

ORIC Pharmaceuticals Inc.San Diego, CA· Yesterday
Legal$145k–$165k/yrapply on jobs.smartrecruiters.com