Global Regulatory Affairs Director - Agricultural Biotechnology #0610

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

Preferred Qualifications

Benefits

Relocation Assistance

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