The Mission Excellent health products are often trapped in local markets. A brilliant formulation in Berlin may never reach a consumer in Boston because the regulatory bridge is missing. At Kensai, we believe regulation should be a filter for excellence, not a barrier to it. We are building the global infrastructure for automated compliance. Our AI engine reads product labels, cross-references them against global legal frameworks (US, UK, EU), and delivers a definitive verdict: "This formulation is valid. This claim is substantiated. This market is open." We don’t sell data; we sell decisions. About the Role This is not a traditional product-level regulatory affairs job. You won't be filing individual notifications or managing supply chains. Instead, you will be the Architect of our regulatory logic. You will map the "Source Infrastructure" of global law into structured, machine-readable decision trees. You will work at the intersection of legal expertise and software engineering to define the rules that power our automated compliance engine. If you are the person who has always wanted to "map the entire system" rather than just navigate one product through it, this role is for you. What You Will Do - Map the Infrastructure: Translate complex frameworks - DSHEA (US), Directive 2002/46/EC (EU and most relevant european countries), and Retained EU Law (UK) - into structured logic (IF/THEN statements, priority hierarchies, and permission sets). - Source Authority: Identify and maintain the "Source of Truth" for official registers (Positive Lists, Negative Lists, Novel Food Catalogs, and Maximum Level Frameworks). - Define Borderlines: Build the logic for "grey-zone" classifications, including NDI status, botanical "borderline" medicines, and novel food triggers. - Logic QA: Validate the regulatory hierarchy of our existing US module and lead the structural build-out for the EU and UK markets. - Risk Signal Integration: Incorporate non-statutory data - FDA Warning Letters and EFSA Safety Opinions - into a weighted "Enforcement Risk" model. - Human-in-the-Loop Design: Explicitly define where automation ends and human legal counsel must begin. What We Need From You The Essentials (Must Haves): - 3-4+ Years in Regulatory Affairs: Specific to dietary supplements or functional food ingredients. - Deep expertise: in at least one jurisdiction (US, EU - focus DE, FR, IT or UK) with working knowledge of the others - and the intellectual framework to close the gaps quickly - Primary Source Fluency: You read the statutory text and the Federal Register, not just the industry blog summaries. - Structural Thinking: You can distinguish between Hard Law (Prohibitions), Soft Law (Guidance), and Risk Signals (Enforcement patterns). - Data Literacy: You are comfortable working with spreadsheets, databases, and decision trees. You think in "systems," not just Word documents. The Edge (Nice to Haves): - Experience with Cross-Jurisdictional Gap Analysis (e.g., why an ingredient is GRAS in the US but "Novel" in the EU). - Background in Pharmacognosy or Food Chemistry to help classify complex botanical extracts. - Familiarity with the CosIng or CPNP structures (if we expand into Cosmetics). What "Good" Looks Like The right person for this role doesn't give "vague" answers. When faced with an ambiguous ingredient, you don't say "it depends", you say: "The legal status is currently a Tier 3 risk because of [Specific Enforcement Action], and here is the logic gate where the software should flag it for manual review." You are as comfortable with an FDA Import Alert as you are with a Statutory Instrument. You are ready to turn your years of regulatory "intuition" into a repeatable, scalable digital architecture. How to Apply Please send your CV and a brief "Logic Sample": Pick one ingredient that is regulated differently in the US vs. the EU, and briefly outline the primary legal sources that create that difference.