Regulatory Affairs Specialist/Fresno-CA Job Fresno area,California USA,Business

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.
Coordinate the development, compilation, review, and maintenance of 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.
Monitor regulatory compliance throughout the product lifecycle, from development through commercialization, and support internal audits as required.
Conduct regulatory research to interpret evolving requirements and apply findings to submission strategies and compliance activities.
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.
Participate in regulatory training, continuous improvement initiatives, and professional development 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 (specially on Adjuvants).
Knowledge about the industry, but focus on adjuvants area (not mandatory).

Required Skills:

Knowledge (theoretical or practical understanding of a subject)
- 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.
Skills (proficiencies developed through training or experience)
- 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 (qualities of being able to do something)
- 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.

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Regulatory Affairs Specialist​/Fresno-CA

Regulatory Affairs Specialist/Fresno-CA