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 – designed to break down the alcohol byproduct that leads to rough mornings after drinking. In 2024, we launched a genetically engineered probiotic drink mix, Sugar-to-Fiber, that creates fiber from the food you eat. This one-of-a-kind product helps to improve the diversity of gut bacteria and overall gut 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. 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. About You You are a regulatory strategist, not simply a compliance operator. You are comfortable creating a playbook where precedent is limited, and you know how to pair scientific rigor with practical business judgment. You build credibility with scientists, executives, counsel, and regulators—and you can advocate persuasively without overstating certainty. You are equally willing to develop a long‑term regulatory position, draft the briefing document, prepare the meeting, and follow through on every commitment. You are proactive, concise, low‑ego, and energized by the responsibility of helping define a new category. Desired Qualifications 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 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. One or both of the following: 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. Additional Helpful Experience 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. This Role is Perfect For You If… You are excited to build a regulatory function and strategy rather than inherit a finished playbook. You want to help define the US and international regulatory framework for evaluating live, genetically engineered biotechnology intended for release in the food system You are energized by novel science, complex questions, and responsible category creation. You combine conviction with intellectual honesty: you advocate clearly, test your own assumptions, and adapt to new evidence. You know how to build trust with regulators and internal partners while maintaining a strong point of view. You want your work to protect product access, consumer trust, company reputation, and long‑term enterprise value. You are humble, open‑minded, collaborative, and comfortable operating in a growing company. You embody the ZBiotics values of People‑first, Integrity, Citizenship, and Science. People‑first — We always put people first, especially our customers. Integrity — We communicate honestly and deliver high quality always. Citizenship — We are inclusive and committed to doing what’s right. Science — We question our own assumptions and adapt to new data. Benefits & Compensation We believe in a life well‑lived. ZBiotics offers competitive benefits for a life outside of work, including: 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, and access to co‑working office space if located in or visiting San Francisco. The base salary range for this position is $210,000 - $240,000 a year, and will include additional equity. A presented offer may be higher, depending on qualifications and experience. Employment at ZBiotics is at‑will. We Encourage You to Apply… At ZBiotics, we value our differences, and we encourage all—especially those whose identities are traditionally underrepresented in tech organizations—to apply. ZBiotics is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, genetic information, veteran status, or any other protected characteristic under applicable federal, state, or local law. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. ZBiotics will provide reasonable accommodations for qualified individuals with disabilities in the application and employment process. If you need assistance or accommodation, please contact ZBiotics HR. Are you legally authorized to work in the United States? Will you now or in the future require sponsorship for employment visa status (e.g., H-1B)? For example, if you are currently working on a Visa or have a pending application for a Visa or work related Visa, please answer Yes to this questions. How many years of direct professional experience do you have working with U.S. FDA regulatory frameworks for foods, food ingredients, and/or dietary supplements? Have you personally led or played a substantial role in at least one of the following: (a) an FDA GRAS 'no questions' submission or comparable food-ingredient submission, or (b) an NDI notification, dietary supplement strategy, claims substantiation, or food-ingredient regulatory filing? Have you directly engaged with FDA (e.g., meetings, pre-submission consultations, formal correspondence) on a novel, first-of-kind, or otherwise ambiguous regulatory matter that specifically involved reducing risk from evolving FDA, GRAS, and state‑level requirements? This role requires periodic travel to Washington, D.C. and other locations, and is based in the U.S. Are you able to travel periodically as needed? This role's base salary range is $210,000–$240,000. Does this range meet your expectations? Please provide a brief/ general summary, if you can, about the regulatory matter that specifically involved reducing risk from evolving FDA, GRAS, and state‑level requirements. Have you recently, in the past 5 years, supported/advised GRAS & NDI strategy and decision‑making? #J-18808-Ljbffr