Global Regulatory Affairs Lead

Global Regulatory Affairs Lead

Vacaville, CA

Oath, a public benefit company, regenerates life in depleted soils globally with naturally occurring, beneficial microorganisms to address some of agriculture's biggest challenges, including yield, nutrient density, and soil health. We imagine a world where these crises are not just alleviated, but reversed, replenishing Earth's microbiomes. By leveraging the latest biotechnologies, Oath provides natural soil inoculant solutions that fosters a healthier and more sustainable world for future generations.

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 projectsincluding 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.

Responsibilities:

• Global Strategy Development: Define and drive the long-term global regulatory roadmap, prioritizing efficient pathways for market entry such as Mutual Recognition (MR) directives and national processes.
• Harmonization & Oversight: Oversee regional regulatory compliance activities, ensuring consistent standards for field release and commercialization permits across all geographies.
• Agency Liaison & Negotiation: 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.
• Regulatory Intelligence: 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.
• Cross-Functional Support: Provide regulatory expertise to Business Development and R&D teams for global research, production and market entry initiatives, labeling, and product development projects.
• Reporting & Governance: Establish global regulatory reporting standards, including documentation of submissions, official communications, and updates on compliance milestones for internal and external stakeholders.

Competencies:

• Strategic Vision: Ability to translate complex, evolving regulatory environments into actionable regulatory strategies in line with commercial plans.
• Global Navigation: Proven ability to work effectively in multinational and multicultural contexts, successfully managing diverse regulatory frameworks simultaneously.
• Communication: Exceptional verbal and written communication skills; capable of simplifying technical regulatory language for commercial stakeholders.
• Agility: A proactive and adaptive mindset when facing changing regulations or unforeseen compliance challenges globally.
• The Big Three: Commitment to Impact, Humility, and Talent (CHaT).

Qualifications:

• Experience: 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.
• Authority: Extensive, hands-on experience with USDA/APHIS, EU regulatory bodies, and local national competent authorities; a strong existing network within these agencies is highly preferred.
• Education: Minimum Master's degree in agricultural engineering, agronomy, forestry, or an adjacent scientific field.
• Certifications: Project management certification (e.g., PMP) is a strong plus.
• Location: Home-based / Remote (USA-based preferred for proximity to North American R&D and commercial activities).