Regulatory Manager, Nutritional

Nufarm•West Sacramento, CA

3d•Onsite

About The Position

Nufarm is seeking an experienced Senior Manager, Regulatory Affairs to play a pivotal role in advancing its global biotech portfolio. This role is responsible for supporting global regulatory strategies and submissions for biotechnology products, including genetic engineering and genome-editing innovations. The position involves partnering closely with R&D, Quality, Commercial, and external stakeholders to ensure regulatory submissions are scientifically robust, strategically aligned, and compliant with global requirements. This is a highly visible role with significant impact on enabling timely product approvals across key international markets.

Requirements

A PhD (preferred) or advanced degree in Plant Sciences, Biotechnology, Molecular Biology, Risk Assessment, Food & Feed Safety, or a related discipline.
10+ years of regulatory affairs experience within agricultural biotechnology organizations.
Extensive knowledge of global GMO and gene-editing regulations, risk assessment frameworks, and regulatory approval pathways.
A successful track record leading global regulatory submissions and interacting directly with regulatory authorities.
Exceptional regulatory writing skills, with experience developing high-quality dossiers, safety assessments, and agency responses.
Strong strategic thinking, with the ability to anticipate regulatory challenges and develop practical approval strategies.
Experience with permits, GLP studies, CRO oversight, and regulatory compliance requirements.
Outstanding communication, influencing, and stakeholder management capabilities.
A proactive, results-oriented mindset with the ability to thrive in a fast-paced, evolving environment.

Responsibilities

Support and implement global regulatory strategies for GMO and gene-edited products across North America, Europe, APAC, and LATAM.
Monitor evolving global regulatory frameworks, assess regulatory risks, and integrate regulatory requirements into development programs.
Lead the preparation, drafting, and review of regulatory dossiers, risk assessments, technical reports, and scientific justifications.
Coordinate complex regulatory submissions and ensure all documentation meets high standards of scientific rigor, compliance, and quality.
Develop strategic responses to regulatory authority questions and data requests, including supporting scientific arguments and regulatory positions.
Build and maintain productive relationships with regulatory agencies and industry stakeholders, supporting meetings, briefings, and technical presentations.
Provide regulatory guidance throughout product development, including study design, permit applications, compliance requirements, and CRO management.
Support the successful advancement of Nufarm's biotechnology innovation pipeline through proactive regulatory leadership.