Director of Regulatory Affairs

Director of Regulatory Affairs | Job Description

About ZBiotics

At ZBiotics, we make genetically engineered probiotics that improve daily life. As a group of motivated, yet down-to-earth people, we are fueled by two things: a love for science and a commitment to being people-first. GMO products like ours - built to create benefits for people in their daily lives - are the future. As the first to market, we believe it’s our duty to set a high bar for product quality, safety, and transparency for others to follow.

In 2019, ZBiotics launched Pre-Alcohol™ - the world's first genetically engineered probiotic drink - designed to break down acetaldehyde, an unwanted alcohol byproduct. In 2024, we launched Sugar-to-Fiber™ - a genetically engineered probiotic drink mix - that creates fiber from the sugar you already eat, contributing to microbiome health.

With a full line of genetically engineered probiotics in development, our team is growing. We’re looking for people as excited as we are to build this new category of consumer products. ZBiotics is headquartered in San Francisco and backed by venture investors including Y Combinator and Khosla Ventures, among others.

About the Role

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.

Your Responsibilities

The following are essential functions of this role:

Own regulatory strategy and product pathways

• Develop and execute a companywide regulatory strategy covering current products, the product pipeline, new markets, and evolving business priorities.
• Define practical, risk-calibrated pathways for product classification, safety and efficacy evidence, claims, labeling, study design, launch sequencing, and market access.
• 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.

Lead regulatory engagement and submissions

• Lead substantive engagement with FDA and other federal, state, and international regulators on novel or ambiguous regulatory questions, building trusted relationships and productive paths forward.
• Own the strategy and execution of GRAS notices, NDI notifications, and other regulatory submissions, including preparing company leaders and technical experts for agency interactions.

Anticipate regulatory and enforcement risk

• Monitor and assess legislation, rulemaking, guidance, enforcement trends, and state-level developments affecting ZBiotics’ products and market access.
• Partner with Legal and executive leadership to identify business implications, establish escalation triggers, plan for likely scenarios, and coordinate timely responses.