Seed Health logo
Seed Health

A microbial sciences company pioneering applications of bacteria to improve human and planetary health.

Regulatory Affairs Manager

ComplianceComplianceFull TimeRemoteSeniorTeam 51-200Since 2015H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

5 days ago

Salary

$130K - $150K / year

Seniority

Senior

Bachelor Degree6 yrs expEnglish

Job Description

Regulatory Affairs Manager

Seed Health

• Support the execution of content and compliance processes. • Collaborate across teams to flag risks, provide regulatory guidance, and keep compliance activities moving. • Contribute to global regulatory and compliance strategy by owning key workstreams across labeling, claims substantiation, ingredient documentation, and product review. • Partner cross-functionally to support product development and brand initiatives. • Conduct ingredient, formula, and packaging compliance reviews according to regulatory frameworks, particularly the U.S. FDCA. • Maintain raw material and formula-level compliance documentation. • Execute compliance reviews consistent with FTC and FDA claims compliance standards. • Serve as day-to-day regulatory contact for Brand, Creative, and Marketing. • Contribute to, review and approve QMS records, particularly labels, formulas, specifications, and change controls. • Integrate Regulatory Affairs into generative AI workflows and maintain accurate customer service messaging.

Job Requirements

  • 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.

Benefits

  • Medical, Dental, Vision, Life, AD&D, LTD, Mental Wellness, EAP, Wellness Stipend + 401(k) match.
  • Choose from multiple medical, dental, and vision plans.
  • Access to top-tier virtual care and a complimentary Aaptiv membership for fitness and mental wellness.
  • HSA with employer contributions, along with Fullscript discounts for supplements.
  • 12 free therapy sessions per year, plus coaching, meditation, and access to Spring Health tools.
  • 401(k) plan featuring a 100% match on the first 3% and 50% on the next 2% of contributions.
  • Parental Leave Policy includes 18 weeks of fully paid leave.
  • 15 vacation days, 7 sick/safe days, 2 personal days, 10 Recharge Days, and 15 paid company holidays each year.
  • $750 one-time remote work setup stipend and ongoing access to a $450 quarterly wellness and workplace stipend via JOON.

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