Regulatory Affairs Manager

Ohalo; South San Francisco (CA); Sur place; USD 110 000 - 155 000; Plein temps

Résumé du poste

Ohalo in San Francisco is seeking a Regulatory Affairs Manager to lead global regulatory market access and compliance across advanced breeding programs. You will drive submissions, ensure import/export compliance for plant materials, and partner with product development and software teams to scale regulatory operations.

The ideal candidate has 5+ years in regulatory affairs for plant biotech, deep knowledge of USDA APHIS PPQ/BRS, and proven ability to implement robust regulatory systems while

Qualifications

• At least 5 years in regulatory affairs or compliance in plant biotech.
• Strong knowledge of USDA APHIS PPQ and BRS.
• Experience with international phytosanitary requirements and import/export permits.
• Experience building regulatory systems and documentation.
• Excellent written and verbal communication; able to simplify complex reg info.

Responsabilités

• Support global regulatory market access and compliance strategies.
• Navigate regulatory submissions and ensure post-approval compliance.
• Oversee import/export compliance for plant materials.
• Develop scalable regulatory tools with engineering teams.
• Collaborate cross-functionally with R&D, Product Development, and Business Development.

Connaissances

Regulatory affairs

Phytosanitary regulation

USDA APHIS PPQ/BRS

Import/Export compliance

Regulatory systems

Cross-functional collaboration

Communication skills

Plant biotechnology

Startup environment

Description du poste

Position Title

Regulatory Affairs Manager

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.

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

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.

About Ohalo

Ohalo™ aims to accelerate evolution to unlock nature's potential. Founded in 2019, Ohalo develops novel breeding systems and improved plant varieties that help farmers grow more food with fewer natural resources, increasing the yield, resiliency, and genetic diversity of crops to sustainably feed our population. Ohalo's breakthrough technology, Boosted Breeding™, will usher in a new era of improved productivity to radically transform global agriculture. For more information, visit www.ohalo.com.

Notes: If you previously applied for a job at Ohalo Genetics, we encourage you to restate your interest in the position by submitting your application.

No visa sponsorship is available for this position at this time.

Ohalo is an Equal Opportunity / Affimative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity or any other factor protected by applicable federal, state or local laws. Ohalo is also committed to working with and providing reasonable accommodations to individuals with disabilities. Please let your recruiter know if you need an accommodation at any point during the interview process.

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