Global Regulatory Affairs Lead

OATH, Inc.; Vacaville (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Oath Inc. seeks a Global Regulatory Affairs Lead to define and execute a worldwide regulatory strategy, ensuring Freedom to Operate for microbial products.

Responsibilities include leading regulatory roadmap across US, EU, and other regions, interfacing with agencies, and aligning with R&D and BD for market entry. This role is home-based/remote within the USA.

Qualifications

• 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; a strong network within these agencies is highly preferred.
• Master's degree in agricultural engineering, agronomy, forestry, or adjacent scientific field.
• 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).

Responsibilities

• Define and drive the long-term global regulatory roadmap, prioritizing efficient pathways for market entry.
• Oversee regional regulatory compliance activities, ensuring consistent standards for field release and commercialization permits.
• Serve as the primary global interface for major regulatory bodies, managing negotiations and coordinating with regional leads.
• Monitor regulatory changes and adapt commercial/product strategies to maintain a competitive advantage.
• Provide regulatory expertise to BD and R&D teams for global research, production and market entry initiatives.
• Establish global regulatory reporting standards and document submissions.
• Translate complex regulatory environments into actionable strategies aligned with commercial plans.
• Navigate multinational regulatory frameworks and manage diverse regulatory requirements.
• Communicate regulatory information clearly to stakeholders.
• Demonstrate CHaT values: Commitment to Impact, Humility, and Talent.

Skills

Regulatory strategy

Global regulatory leadership

Cross-functional collaboration

Regulatory negotiations

Communication

Education

Master's degree in agricultural engineering, agronomy, forestry, or adjacent scientific field

Job description

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, butreversed, replenishing Earth's microbiomes. By leveraging the latest biotechnologies, Oathprovides natural soil inoculant solutions that fosters a healthier and more sustainable world for
future generations.

Position Summary:

The Global Regulatory Affairs Lead is responsible for defining and executing Oath’s globalregulatory strategy to achieve and maintain "Freedom to Operate" (FTO) for our microbial productportfolio. This role provides strategic oversight for regional regulatory projects—including US stateregistrations, EU FPR (2019/1009), EU member state legacy processes, and registrations in theMiddle 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 theapplicationof local regulatory best practices to and adherence to specific country legislation,
monitor international policy shifts, and ensure high-level compliance across all jurisdictions tofacilitate 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) directivesand national processes.
• Harmonization & Oversight: Oversee regional regulatory compliance activities, ensuringconsistent standards for field release and commercialization permits across allgeographies.
• Agency Liaison & Negotiation: Serve as the primary global interface for major regulatorybodies, managing high-level negotiations and coordinating with regional leads or localcontractors to build fit-for-purpose dossiers and resolving complex compliance hurdles.
• Regulatory Intelligence: Monitor, interpret, and communicate changes in the globalregulatory environment (e.g., EC 2019/1009, USDA/APHIS updates, the evolving regulationsin Brazil) and adapt commercial/product strategies to maintain a competitive advantage.
• Cross-Functional Support: Provide regulatory expertise to Business Development and R&Dteams for global research, production and market entry initiatives, labeling, and productdevelopment projects.
• Reporting & Governance: Establish global regulatory reporting standards, includingdocumentation of submissions, official communications, and updates on compliancemilestones for internal and external stakeholders.
• Strategic Vision: Ability to translate complex, evolving regulatory environments intoactionable 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 andEuropean markets.
• Authority: Extensive, hands-on experience with USDA/APHIS, EU regulatory bodies, andlocal national competent authorities; a strong existing network within these agencies ishighly preferred.
• Education: Minimum Master’s degree in agricultural engineering, agronomy, forestry, or anadjacent 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 andcommercial activities).

As set forth in Oath’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.