Regulatory Affairs Specialist/Fresno-CA

Essential Duties and Responsibilities

• Prepare, submit, and maintain U.S. product registration dossiers, including new registrations, label amendments, renewals, and associated regulatory activities.
• Develop and implement regulatory submission strategies in collaboration with technical, marketing, and cross-functional teams to support commercial objectives.
• Serve as the primary regulatory liaison with internal departments, regulatory authorities, consultants, and global team members to troubleshoot issues and expedite project timelines.
• Capture and maintain technical documentation, including product labels, supporting literature, and registration dossiers.
• Collaborate with global and regional stakeholders to develop and maintain data dossiers for existing and new products.
• Evaluate and provide regulatory guidance on raw materials, formulation changes, and product modifications to ensure regulatory compliance and product conformity.
• Maintain accurate and current regulatory databases, records, and filing systems in accordance with internal and regulatory requirements.
• Uphold strict confidentiality of company business information and regulatory data.
• Conduct regulatory research to interpret evolving requirements and apply findings to submission strategies and compliance activities.
• Perform other related regulatory or administrative tasks as assigned.

Key Performance Areas

• Product Registration Management (North America)
• New product registrations
• Label amendments
• Registration maintenance and renewals
• Regulatory Strategy and Compliance
• Regulatory research and interpretation
• Development and execution of submission strategies
• Regulatory Operations
• Recordkeeping, document control, filing, and timekeeping
• Training and Professional Development
• Ongoing learning, process improvements, and knowledge sharing

Required Education and Experience

• Bachelor’s degree in a relevant scientific discipline such as Biology, Chemistry, Toxicology, or a related field.
• Master’s Degree preferred.
• Minimum of two (2) years of experience in a regulatory affairs role within an agrochemical or similarly regulated industry.
• Experience working with U.S. regulatory requirements for agricultural products, including crop protection products, plant nutrition, bio-stimulants, biopesticides, and/or adjuvants.
• Practical experience interpreting and applying scientific and technical documentation, including trial, efficacy, and toxicology reports.
• Familiarity with regulatory compliance processes, documentation standards, and routine regulatory operations (especially on Adjuvants).
• Knowledge about the industry, but focus on adjuvants area (not mandatory).

Required Skills

• Knowledge of U.S. regulatory frameworks applicable to agricultural products and their registration, labeling, and lifecycle management.
• Understanding of import, export, and transportation regulations, including DOT, IMDG, IATA, EPA, TSCA, FDA, and USDA requirements.
• Knowledge of SDS/GHS requirements, including content standards and regulatory compliance expectations.
• Understanding of corporate procedures, document control, and recordkeeping requirements in a regulated environment.
• Ability to interpret and apply regulatory requirements to support product registrations, label amendments, and compliance activities.
• Proficiency in Microsoft Office applications (Word, Excel, Outlook, PowerPoint).
• Strong technical writing skills with the ability to prepare accurate, clear, and compliant regulatory submissions and documentation.
• Effective time-management and organizational skills, with the ability to manage multiple projects and deadlines simultaneously.
• Strong analytical and problem-solving skills to address regulatory challenges efficiently.

Abilities

• Ability to work independently as a self-starter in a fast-paced, deadline-driven environment.
• Ability to maintain a high level of ethical conduct and confidentiality of sensitive company and regulatory information.
• Ability to communicate clearly and professionally, both verbally and in writing, with internal stakeholders and external regulatory authorities.
• Ability to learn quickly, adapt to changing regulatory requirements, and respond effectively to evolving business needs.
• Ability to prioritize tasks, maintain accuracy, and consistently meet regulatory and business deadlines.
• Ability to interact confidently and professionally with internal teams, global stakeholders, consultants, and regulatory agencies.