Regulatory Affairs Manager

Ohalo•South San Francisco, CA

17h•$110,000 - $155,000

About The Position

Ohalo is seeking a Regulatory Affairs Specialist to support global regulatory market access and compliance across its advanced breeding R&D and product development programs. The position is a point person for navigating complex regulations, supporting global regulatory submissions, ensuring compliant import and export operations for plant materials, and working with the Ohalo team to maintain regulatory compliance. The role operates at the intersection of regulatory strategy, innovation, and commercial launch, and is responsible for developing systems that make regulatory operations more efficient and scalable as Ohalo grows. The role supports USDA APHIS compliance, including PPQ and BRS requirements; helps develop and submit global regulatory dossiers; coordinates technical data, safety assessments, and agronomic evidence; and supports international approvals and post-approval compliance. It also develops protocols for compliant movement of plant materials, monitors import/export and phytosanitary requirements, and ensures associated documentation and logistics meet regulatory requirements. The manager partners with internal teams to develop scalable regulatory tools and workflows and to incorporate regulatory considerations into product timelines and go-to-market strategies. Ohalo develops novel breeding systems and improved plant varieties intended to help farmers grow more food with fewer natural resources. The company was founded in 2019. The role is full-time and based in San Francisco. The anticipated base pay range is $110,000–$155,000 per year. Visa sponsorship is not available for this position.

Requirements

At least 5 years of industry experience in regulatory affairs or regulatory compliance, focused on plant biotechnology, advanced breeding, or closely related agricultural biotech sectors.
Strong knowledge of USDA APHIS regulations, particularly PPQ and BRS frameworks, and demonstrated ability to navigate complex regulatory environments.
Understanding of international phytosanitary requirements and experience with import/export permitting for plant materials.
Track record of building and implementing regulatory systems, processes, or documentation solutions to improve the efficiency of regulatory operations.
Strong written and verbal communication skills and ability to synthesize complex regulatory information for technical and non-technical audiences.
Comfort working in a fast-paced startup environment, with a bias toward speed, problem-solving, and ownership.
Ability to work cross-functionally with diverse teams and comfort learning new domains, such as software engineering and product development.
Experience in the plant science or agriculture industry.

Responsibilities

Support compliance with USDA APHIS regulations, specifically PPQ and BRS, for advanced breeding R&D and product development.
Build and maintain relationships with regulatory contacts, track regulatory changes, and ensure timely organizational awareness and adoption.
Support the development and submission of regulatory dossiers for global product clearance.
Coordinate with internal teams to compile technical data, safety assessments, and agronomic evidence for submissions.
Help shepherd submissions through international approval processes in key markets and maintain compliance after approval.
Develop and maintain protocols for the compliant movement of plant materials in key markets.
Stay current with evolving import/export regulations and phytosanitary requirements, and ensure documentation and logistics meet regulatory requirements.
Partner with Business Development and Commercial teams to support the transfer of Ohalo materials to partners around the world.
Identify inefficiencies in regulatory operations and design scalable solutions.
Work independently and with Software Engineering, as appropriate, to build tools and systems that streamline submissions, tracking, compliance monitoring, and reporting.
Own the continuous improvement of regulatory workflows within Ohalo.
Partner with Research & Development, Product Development, Software Engineering, and Business Development to ensure regulatory requirements are understood and to accurately project timelines and go-to-market strategies.
Communicate regulatory risks and opportunities clearly and early, supporting compliance as an enabling function for the business.