Global Regulatory Affairs Lead

OathVacaville, CA
Remote

About The Position

The Global Regulatory Affairs Lead is responsible for defining and executing Oath’s global regulatory strategy to achieve and maintain "Freedom to Operate" (FTO) for our microbial product portfolio. This role provides strategic oversight for regional regulatory projects—including US state registrations, EU FPR (2019/1009), EU member state legacy processes, and registrations in the Middle East, Turkey as well as Central and Latin America. A critical component of this role is personal accountability for all USDA/APHIS permitting. The Global Lead will prioritize the application of local regulatory best practices to and adherence to specific country legislation, monitor international policy shifts, and ensure high-level compliance across all jurisdictions to facilitate smooth commercial market entry and sustained growth.

Requirements

  • 10+ years of dedicated experience in Regulatory Affairs within the agricultural, biostimulant, or microbial product sectors, with demonstrated experience in US, Brazil and European markets.
  • Extensive, hands-on experience with USDA/APHIS, EU regulatory bodies, and local national competent authorities.
  • Minimum Master’s degree in agricultural engineering, agronomy, forestry, or an adjacent scientific field.

Nice To Haves

  • A strong existing network within regulatory agencies is highly preferred.
  • Project management certification (e.g., PMP) is a strong plus.

Responsibilities

  • Define and drive the long-term global regulatory roadmap, prioritizing efficient pathways for market entry such as Mutual Recognition (MR) directives and national processes.
  • Oversee regional regulatory compliance activities, ensuring consistent standards for field release and commercialization permits across all geographies.
  • Serve as the primary global interface for major regulatory bodies, managing high-level negotiations and coordinating with regional leads or local contractors to build fit-for-purpose dossiers and resolving complex compliance hurdles.
  • Monitor, interpret, and communicate changes in the global regulatory environment (e.g., EC 2019/1009, USDA/APHIS updates, the evolving regulations in Brazil) and adapt commercial/product strategies to maintain a competitive advantage.
  • Provide regulatory expertise to Business Development and R&D teams for global research, production and market entry initiatives, labeling, and product development projects.
  • Establish global regulatory reporting standards, including documentation of submissions, official communications, and updates on compliance milestones for internal and external stakeholders.
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