Global Regulatory Affairs Director

A premier agricultural biotechnology firm based in South San Francisco is looking for a Global Regulatory Affairs Director to drive their international expansion in sustainable agriculture through genomic innovation and advanced plant science. This is a newly established position that presents a unique opportunity to develop regulatory strategies for next- generation gene-edited crop solutions and establish novel regulatory frameworks within a rapidly expanding organization. In this role, you will report directly to the Chief Administrative Officer and Chief Legal Officer, leading international regulatory submissions, compliance monitoring, and multi-jurisdictional product registration activities for revolutionary agricultural biotechnology innovations. You'll collaborate with exceptional talent while advancing transformative technology toward commercialization. Primary Responsibilities Manage International Submissions : Direct regulatory submission processes, documentation oversight, and compliance monitoring across diverse agricultural and biotechnology regulatory systems in multiple territories (encompassing LATAM, India, Africa, Australia, and EU) Cross-Functional Leadership : Work in close partnership with Legal, Product Development, and Commercial divisions to align scientific, legal, and business objectives for accelerated execution Navigate Complex Regulatory Frameworks : Create and implement market-entry strategies across various geographies; handle import / export compliance matters including permits, customs protocols, and phytosanitary regulations Develop Global Regulatory Roadmaps : Lead preliminary development of approval pathways to secure worldwide regulatory clearances for [Crop #2] and future product lines; manage the complete regulatory affairs lifecycle Lead Regulatory Operations for Product Launches : Assume control of recently initiated approval processes for [Crop #1] across the US and multiple international markets; take comprehensive responsibility for regulatory affairs operations supported by Legal, Product Development, and Commercial functions Track Performance Metrics : Establish and monitor regulatory performance indicators emphasizing efficiency, compliance readiness, and approval timelines Stakeholder Management : Liaise with CROs (Contract Research Organizations), regulatory advisors, commercial collaborators, and governmental bodies; participate in regulatory advocacy initiatives with regulatory authorities Build Scalable Processes : Create regulatory standard operating procedures, guidance documents, and repeatable workflows that will establish the infrastructure for the organization's regulatory affairs capabilities Requirements Regulatory expertise encompassing agricultural biotechnology regulation (GMO versus non-gmo categorization), international frameworks for gene editing, GMO authorization processes, seed legislation and variety registration, biosafety protocols and phytosanitary trade standards Proven track record managing international seed / plant regulatory approvals, including CRISPR-edited or genetically modified crops 5+ years of professional experience in agricultural biotechnology regulatory affairs, seed / variety registration processes, or agricultural product commercialization, with documented success obtaining approvals across various jurisdictions Entrepreneurial approach with first-principles thinking for problem-solving Hands-on, detail-focused professional with an emphasis on speed and results delivery Excellent written and verbal communication capabilities, demonstrating precision in documentation, reporting, and stakeholder communications Comprehensive understanding of international regulatory systems governing gene editing, GMOs, seed regulations, biosafety standards, and phytosanitary commerce Strong project management capabilities with the capacity to advance complicated, cross-functional, multi-national projects efficiently Operational proficiency in directing international regulatory submissions, developing market-access strategies, and managing import / export compliance activities Flexibility in adapting to evolving regulatory environments and dynamic startup settings Robust cross-functional leadership skills, collaborating productively with Legal, Product Development, and Commercial departments Preferred Qualifications Background in plant science, biotechnology, or genetics disciplines Familiarity with DUS / VCU testing protocols and non-gmo certifications Experience establishing regulatory departments or functions from inception Knowledge of food / feed safety authorization processes and trade regulations Flexibility in managing multiple responsibilities and assuming ownership of varied initiatives within a startup setting Benefits Base Salary : $150,000 - $190,000 100% company-paid PPO health insurance for single coverage (competitive contribution for dependents) 401(k) retirement plan Paid parental leave Wellness stipends Competitive PTO Relocation Assistance Lump-sum relocation stipend available; taxable benefit billable against relocation expenses. 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