Director of Regulatory Affairs

ZBiotics

Director of Regulatory Affairs leading ZBiotics’ regulatory and policy strategy for innovative probiotics. Collaborating with regulatory bodies and managing product classification and market access.

Posted 7/21/2026full-timeRemote • California • 🇺🇸 United StatesLead💰 $210,000 - $240,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in regulatory affairs and policy strategy, particularly within the U.S. FDA frameworks for foods and dietary supplements. Proven ability to engage with regulators, interpret complex regulations, and support international market access through strategic planning and evidence generation.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA EngagementGRAS Submission ExpertiseDietary Supplement StrategyTechnical Writing Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory StrategyProduct ClassificationClaims SubstantiationLabeling ComplianceMarket Access EvaluationScientific LiteracyBiotechnology KnowledgeMicrobiology UnderstandingFood Law ExpertiseNDI Notification Experience

Soft Skills

Coalition-BuildingCross-Functional LeadershipOral AdvocacyPragmatic Decision-MakingRisk Assessment

Industry Keywords

FDA FrameworksFood IngredientsDietary SupplementsRegulatory PathwaysPublic PolicyLegislative ExperienceEmerging RegulationsConsumer CommunicationsSafety DocumentationBiological Sciences

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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