Sr. Manager or Director, Regulatory Affairs

Checkerspot Biosciences is a category-defining biotechnology company tailoring fats and oils via precision fermentation. The company develops functional lipids not easily or sustainably sourced from nature, enabling premium brands to access market-ready ingredients that advance health, wellness, and quality of life.

We seek a hands-on regulatory leader to join Checkerspot Biosciences as Sr. Manager or Director of Regulatory Affairs. Checkerspot Biosciences licenses its ingredient technologies to manufacturing and commercialization partners, and the role is primarily responsible for establishing the regulatory basis for each technology and working with those partners to bring ingredients to market with the appropriate approvals in the United States and priority international markets.

This includes ownership of engagement with the U.S. Food and Drug Administration (FDA) and oversight of Quality Assurance (QA) and Quality Control (QC) requirements for partner manufacturing.

Key responsibilities include:

• Develop regulatory strategies for each ingredient technology by evaluating FDA Generally Recognized as Safe (GRAS), food additive, New Dietary Ingredient Notification (NDIN), and international novel food pathways based on ingredient identity, manufacturing process, intended uses, use level, target populations, and markets, and advise leadership on the implications for portfolio priorities, partner and market sequencing, proposed claims, and expansion into new applications or markets
• Lead regulatory execution across the product portfolio through integrated plans with clear milestones, deliverables, responsibilities and timelines, coordinating internal and external resources, resolving obstacles, and communicating progress, risk and decisions requiring leadership input.
• Serve as Checkerspot’s principal FDA contact and own GRAS notice preparation, submission, agency responses, amendments, and resubmissions, including submissions prepared with or for partners
• Direct complete dossiers covering identity, manufacturing, specifications, intended uses, dietary exposure, and the basis for safety and general recognition of safety, including unfavorable evidence, as the baseline regulatory package in each technology transfer
• Direct and manage external regulatory consultants and counsel, including scopes of work, deliverables, timelines, and budgets, while critically reviewing their work and retaining internal ownership of regulatory strategy, technical positions, and submission quality.
• Work with scientists and external experts to close evidence gaps through analytical, toxicological, nutritional, exposure, and allergenicity assessments, production-organism identity and safety assessment, and lipid characterization
• Prioritize international market access, lead or coordinate European Union novel food applications through European Food Safety Authority (EFSA) assessment and authorization, and work with partners and local specialists in other priority markets
• Lead QA/QC with Quality, Operations, and manufacturing partners, defining accountability for compliance, escalation, and product release; food current Good Manufacturing Practices and Food Safety Modernization Act requirements; and specifications, testing, and certificates of analysis
• Oversee, with manufacturing partners, deviation investigations, corrective and preventive actions, change control, audits, traceability, and recall preparedness, and resolve quality concerns before commercial release
• Integrate regulatory requirements into scale-up, technology transfer packages, and partner qualification, and assess the regulatory impact of changes to strains, processes, sites, specifications,…