Director of Regulatory Affairs

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🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $210k - $240k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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ZBiotics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2016

🧬 Biotechnology

👥 B2C

🛍️ eCommerce

💰 Secondary Market - ZBiotics on 2025-03

Biotechnology • B2C • eCommerce

ZBiotics is a biotechnology company that engineers probiotic Bacillus subtilis strains into consumer-facing products designed to improve everyday health outcomes. Their flagship product, Pre-Alcohol, is a genetically engineered probiotic drink that produces an enzyme to break down acetaldehyde (a toxic alcohol byproduct) in the gut to reduce hangover-related effects, and their Sugar-to-Fiber product uses engineered probiotics to convert dietary sucrose into prebiotic levan fiber to support gut microbiome health. ZBiotics operates primarily as a direct-to-consumer brand via e-commerce and retail channels and positions itself as bringing applied synthetic biology to everyday wellness products.

📋 Description

• Own and execute ZBiotics’ U.S. and international regulatory and policy strategy • Advise on product classification, GRAS and NDI strategy, claims, labeling, studies, launches, and market access • Lead substantive engagement with regulators • Monitor and respond to emerging federal, state, and international requirements • Coordinate internal and external experts needed to execute • Review product concepts, formulas, specifications, labels, claims, consumer communications, studies, and launch plans for regulatory implications • Help teams generate evidence and documentation needed to support safety, intended use, claims, and regulatory positions • Support international expansion by evaluating market requirements, selecting practical pathways, and coordinating local expertise

🎯 Requirements

• 10+ years of relevant experience in regulatory affairs, regulatory policy, government affairs, food law, or a closely related field • Deep knowledge of U.S. FDA frameworks for foods, food ingredients, and/or dietary supplements • Direct experience engaging with FDA and navigating novel, first-of-kind, or ambiguous regulatory pathways • Successful involvement in FDA GRAS “no questions” processes or comparable food-ingredient submission • Experience with NDI notifications, dietary supplement strategy, claims substantiation, labeling, or food-ingredient regulation • Demonstrated ability to interpret emerging laws, regulations, guidance, and enforcement signals and convert them into business strategy • Strong scientific literacy, ideally including biotechnology, microbiology, probiotics, synthetic biology, or another technically complex field in the biological sciences • Coalition-building, trade-association, legislative, or public-policy experience • Excellent technical writing and oral advocacy skills • Experience leading cross-functional work and managing outside counsel, consultants, and subject-matter experts • High judgment and the ability to make pragmatic, risk-calibrated recommendations with incomplete information.

🏖️ Benefits

• health / dental • 401(k) matching • a flexible, unlimited paid time off policy • 16 weeks fully paid parental leave • a home office stipend • transit benefits for those in the San Francisco Bay Area • access to co-working office space if located in or visiting San Francisco