Sr. Manager or Director, Regulatory Affairs

COMPANY DESCRIPTION

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.

PRINCIPAL RESPONSIBILITIES

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:

KEY RESPONSIBILITIES

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, formulations, and uses Work with Quality, Operations, and Legal on license, manufacturing, and quality agreements, including allocation of regulatory responsibilities, confidentiality, and data protection; maintain regulatory files and track regulatory developments Present safety, compliance, and evidence limitations at development, technology transfer, and partner launch-readiness reviews Support partners in customer qualification with regulatory status statements, safety summaries, and specifications, and review proposed labeling, marketing materials, and claims against the supporting evidence

KEY REQUIREMENTS

Bachelor’s degree in food science, toxicology, microbiology, biochemistry, chemistry, nutrition, biotechnology, biological engineering, or a closely related discipline 10 or more years of progressively responsible regulatory experience with food ingredients, nutrition, or food biotechnology, including at least three years leading regulatory strategy, teams, or cross-functional programs; industry or specialized consulting experience is acceptable Hands-on preparation and submission of GRAS notices and management of substantive FDA review through agency responses; self-determined GRAS conclusions or general familiarity do not meet this requirement Knowledge of U.S. food-ingredient regulation, including GRAS and food additive pathways, exposure assessment, labeling, and claims, and experience with NDINs; pharmaceutical or medical-device experience alone does not meet this requirement Ability to evaluate safety, nutritional, exposure, analytical, and manufacturing data, identify material evidence gaps, and work with technical experts Experience overseeing or working closely with food QA/QC and manufacturing teams, including contract or partner manufacturers, food-safety systems, supplier qualification, investigations, and audit readiness Ability to lead multidisciplinary teams across competing priorities and manage projects, budgets, external providers, and partners Prepares and reviews technical work directly, with attention to documentation, data integrity, consumer safety, and accurate communications

PREFERRED QUALIFICATIONS

Master’s degree or Ph.D. in a relevant scientific discipline, or training in regulatory science, food law, or risk assessment Multiple FDA GRAS notices led to “no questions” responses, particularly for novel, fermentation-derived, or specialty lipid ingredients EU novel food dossier and authorization experience, and market-access experience in Canada, the United Kingdom, Australia/New Zealand, Singapore, or China Experience with microalgal or other microbial platforms, specialty fats and oils, structured triglycerides, or bioactive fatty acids Experience with infant formula or other specialized nutrition ingredients Experience with safety assessment of personal care ingredients Experience building regulatory or quality systems in a growing company, supporting technology transfer or licensing, and moving ingredients into commercial supply with external manufacturers

BENEFITS

Checkerspot Biosciences offers its employees a competitive benefits and compensation package. The expected pay range for this role is $160,000 to $200,000 annually with final determination on salary and title commensurate with experience. Checkerspot Biosciences is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, genetic information, age, disability, veteran status, or any other legally protected basis. #J-18808-Ljbffr Breakout Ventures