Regulatory Affairs Specialist

About the role

• Position Title: Regulatory Affairs Manager
• Location: San Francisco
• Type: Full Time

The Opportunity

Ohalo is seeking a Regulatory Affairs Specialist to support global regulatory market access and compliance efforts across our advanced breeding R&D and product development programs.

In this role, you will be the point person for navigating complex regulations, supporting global regulatory submissions, ensuring seamless import/export operations for our plant materials, and working alongside other members of the Ohalo Team to ensure regulatory compliance.

You'll work at the intersection of regulatory strategy, innovation, and commercial launch, building systems that make our regulatory operations more efficient and scalable as Ohalo grows.

Responsibilities

USDA APHIS Operational Compliance

Support compliance with USDA APHIS regulations, specifically PPQ (Plant Protection and Quarantine) and BRS (Biotechnology Regulatory Services), for our advanced breeding R&D and product development efforts; build and maintain relationships with regulatory contacts; track regulatory changes and ensure timely organizational awareness and adoption.

Global Regulatory Submissions & Stewardship

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; help shepherd submissions through international approval processes in key markets; maintain compliance post-approval.

Import/Export Compliance

Develop and maintain protocols for the compliant movement of plant materials in key markets of interest to Ohalo; stay current with evolving import/export regulations and phytosanitary requirements; ensure documentation and logistics meet all regulatory requirements. Partner with Business Development and Commercial Teams to ensure the successful transfer of Ohalo materials to our partners around the world.

Systems & Tools Development

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.

Cross-Functional Collaboration

Partner closely with Research & Development, Product Development, Software Engineering, and Business Development to ensure regulatory requirements are understood and accurately project timelines and go-to-market strategies; communicate regulatory risks and opportunities clearly and early. Make regulatory compliance an enabling function that drives our business forward while ensuring compliance with agriculture laws and regulations.

Candidate Profile

• At least 5 years of industry experience in regulatory affairs / regulatory compliance, with a focus on plant biotechnology, advanced breeding, or closely related agricultural biotech sectors.
• Strong knowledge of USDA APHIS regulations, particularly PPQ and BRS frameworks; 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, and/or documentation solutions to improve the efficiency of regulatory operations.
• Strong written and verbal communication skills; ability to synthesize complex regulatory information for technical and non-technical audiences.
• Comfort working in a fast-paced, startup environment; bias toward speed, problem-solving, and ownership.
• Ability to work cross-functionally with diverse teams; comfort learning new domains (e.g., software engineering, product development).
• Experience in the plant science or agriculture industry

Pay and benefits

The anticipated base pay range for this role is $110,000 - $155,000 per year for our San Francisco location. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, budget availability, internal equity, geographic location and external market pay for comparable jobs.