Regulatory Specialist Mexico

**Description**:
The Regulatory Specialist will provide technical/regulatory support for Crop Protection & Fertilizer products according to the Mexican Regulatory Framework. Build and submit dossiers for new registrations, renewals, label amendments, new uses and new sources in the Mexican Regulatory Agency (COFEPRIS). Coordinate reviews of product labels. Prepare/Submit/Manage all the documents needed for a successful registration. Maintains regulatory records and databases as well, contributes to enhancements to information digital management.

**Activities**:

- Regulatory Framework: Stay updated on the regulatory framework governing Crop Protection & Fertilizers products in Mexico, including laws, regulations, guidelines, and requirements set by government agencies such as the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and the Ministry of Agriculture and Rural Development (SADER).
- Product Registration: Support the Crop Protection & Fertilizers registration process, including preparing and submitting registration dossiers, coordinating with regulatory authorities, and responding to their queries or requests for additional information. Monitor and track the progress of registrations and renewals.
- Labeling and Documentation: Develop and review product labels, ensuring compliance with regulatory requirements, including proper language, hazard statements, precautionary measures, and safety information. Maintain accurate and up-to-date documentation related to product registrations and labeling.
- Regulatory Submissions: Prepare and submit required reports, notifications, and regulatory submissions to regulatory authorities, such as periodic pesticide reports, sales data, and import/export documentation. Ensure timely and accurate submissions to maintain compliance.
- Regulatory Intelligence: Monitor regulatory developments, industry trends, and changes in regulations or policies related to pesticide products in Mexico. Assess the potential impact on the company's products and operations and provide recommendations for necessary actions or adjustments to maintain compliance.
- Cross-functional Collaboration: Work closely with internal teams, such as R&D, Marketing, and Sales, to gather necessary information for regulatory submissions, label development, and compliance activities. Collaborate with external stakeholders, such as consultants, trade associations, and regulatory authorities.
- Compliance Activities: Support internal compliance activities to ensure adherence to regulatory requirements, identify potential gaps or non-compliance issues, and implement corrective actions. Prepare and support external regulatory inspections or audits, providing requested information and addressing any findings or inquiries.

**Qualifications**:

- Bachelor's Degree in Life science or related discipline (Agronomist, Chemical Engineer, Biotechnology, Chemistry, Biology, Environmental Engineer, etc).
- Desirable experience and understanding of the pesticides regulation in Mexico (COFEPRIS, SEMARNAT and SADER).
- Good, solid interpersonal communication (oral and written) and organization skills.
- Advanced communication in English (oral and written).
- Ability to work on several projects, with direction from senior staff as appropriate.
- Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements.
- Ability to make decisions on discrete tasks under senior supervision.
- Must be able to work both alone and as part of a team and have the ability to concentrate on large volumes of written/paper-based work in an office environment.
- The incumbent should possess a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work.