Director of Regulatory Affairs

ZBiotics•San Francisco, CA

1d•$210,000 - $240,000•Hybrid

About The Position

As Director of Regulatory Affairs, you will own and execute ZBiotics’ U.S. and international regulatory and policy strategy. You will help define the pathways that allow first-of-kind consumer biotechnology products to reach people safely, responsibly, and at scale. This is a senior, hands-on leadership role for a strategist who can also drive the work. You will 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; and coordinate the internal and external experts needed to execute. You will turn ambiguity into a clear, risk-calibrated regulatory plan—and ensure that plan moves forward. You will report to our CEO and work closely with R&D, Scientific Affairs, Quality, Legal, Product, Marketing, Operations, and executive leadership. This role will initially be an individual contributor, with the opportunity to shape the regulatory function as ZBiotics grows. Review product concepts, formulas, specifications, labels, claims, consumer communications, studies, and launch plans for regulatory implications. Help teams generate the 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, with senior ownership of strategy and execution.
Deep knowledge of U.S. FDA frameworks for foods, food ingredients, and/or dietary supplements, including meaningful experience with GRAS and related safety and submission strategies.
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, including the ability to communicate clearly with both specialist and non-specialist audiences.
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.

Nice To Haves

Existing relationships within FDA or relevant federal regulatory and policy communities.
Experience working with state regulators or policymakers, particularly in California and New York.
International regulatory experience and a track record supporting entry into new markets.
Experience in consumer biotechnology, novel foods, functional foods or beverages, probiotics, health and wellness, or another science-led consumer category.
Advanced scientific degree, law degree, regulatory credential, or equivalent experience.
Experience at a startup or small company where you’ve helped build new processes or policies from scratch.

Responsibilities

Build the regulatory operating system: Establish the processes, decision records, calendars, controls, and documentation needed for consistent regulatory execution and audit readiness.
Maintain a clear portfolio view of regulatory priorities, dependencies, risks, owners, and deadlines.
Select, direct, and hold accountable outside counsel, regulatory consultants, scientific experts, and other external partners.
Create concise executive updates and recommendations that make tradeoffs, uncertainty, and required decisions easy to understand.
Shape the external environment: Represent ZBiotics with policymakers, industry associations, scientific organizations, and other external stakeholders.
Identify opportunities for constructive policy engagement and thought leadership around engineered live products and responsible consumer biotechnology.
Help build coalitions or industry initiatives where collective action can improve regulatory clarity and strengthen appropriate standards.