Director of Regulatory Affairs

About the role

ZBiotics is a company that develops genetically engineered probiotics aimed at improving daily life. The company was founded with a mission to create safe and beneficial products for consumers. Key milestones include launching Pre-Alcohol in 2019 and Sugar-to-Fiber in 2024. The company is headquartered in San Francisco and backed by prominent venture capital firms.

Responsibilities

• Own and execute ZBiotics' U.S. and international regulatory and policy strategy
• Define pathways for first-of-kind consumer biotechnology products
• Advisory on product classification, GRAS and NDI strategy, claims, labeling, studies, and launches
• Lead substantive engagement with regulators
• Monitor and respond to emerging federal, state, and international requirements
• Coordinate internal and external experts for execution

Qualifications

• 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 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

Desired Qualifications

• 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

Benefits & Compensation

• Competitive benefits package including health/dental insurance, 401(k) matching, flexible paid time off, 16 weeks fully paid parental leave, home office stipend, transit benefits, and access to co-working office space
• Base salary range: $210,000 - $240,000 per year, with potential for higher offers based on qualifications and experience
• At-will employment
• Reasonable accommodations for qualified individuals with disabilities