Product Regulatory Affairs Analyst

Omya Interantional AG; Santa Catarina; Presencial; MXN 480.000 - 600.000; Jornada completa

Descripción de la vacante

Omya Interantional AG in Mexico is seeking a Regulatory Affairs Specialist to support regulatory assessment and product registrations for customers and markets. You will assist in registrations for agricultural products across Latin America and prepare license variations while monitoring renewal timelines.

You will manage product information, ensure regulatory-compliant documentation, coordinate translations, and respond to inquiries.

Formación

• Bachelor’s degree in Chemistry, Government Affairs, Toxicology, Biology or Environmental.
• Minimum 3 years of product regulatory work experience.
• Fluent in English and Spanish; Portuguese helpful.
• Knowledge of Latin America regulatory requirements.
• Strong documentation and data management skills.
• Excellent communication and organizational abilities.

Responsabilidades

• Support the regulatory assessment and registrations to Omya customers and markets.
• Assist registration of agricultural products focusing on Latin America.
• Prepare license variations and renewals and monitor timelines.
• Create and review product information and technical documentation.
• Ensure translations meet local requirements.
• Respond to regulatory inquiries and support sales teams.
• Maintain data integrity in regulatory databases.
• Contribute to QSHE compliance practices.

Conocimientos

Regulatory knowledge

Regulatory databases

Documentation writing

Project management

English & Spanish

Educación

Bachelor's Degree in Chemistry

Herramientas

MS Office

Regulatory databases

Descripción del empleo

Support the regulatory assessment and registration to known statutory regulations as appropriate or needed by Omya customers and markets. Ensure product information and technical documentation is in strict compliance with customer’s requirement, regulations and industry standards.

JOB RESPONSIBILITIES

Product Registration Process Support

• Support the innovation teams and regions to get the necessary approvals for new products and substances. Actively supports registrations, for Omya Group manufactured and distributed products, where appropriate and coordinate related third party activities.
• Assist in the registration of agricultural products, focusing on South America.
• Prepare submissions of license variations and renewals; Monitor and set timelines for license variations and renewal approvals.
• Contribute towards processes and documentation to ensure that they incorporate local requirements.
• Identify issues and improvement opportunities, propose solutions and participate in implementation of improvement initiatives.

Product/Technical Documentation

• Prepare and deliver product information and technical documentation in a timely manner, according to regulatory requirements.
• Manage and oversee collecting, collating and evaluating scientific data that has been researched by teams for Omya products.
• Generate technical reports and declarations for internal and external use.
• Review all product information to ensure 100% accuracy and completeness.
• Ensure product’s information is in strict compliance with customers’ requirements, regulations and industry standards.
• Communicate directly with Sales force/Customer Service regarding generation of product documentation.
• Ensure all relevant translations are conducted and validated to local requirements.
• Participate in determining the appropriate regulatory content for product labels, authoring Safety Data Sheets (SDSs).

Data & Process Management

• Review and update new regulations into systems, in coordination with local Regulatory team.
• Perform data cleaning using existing methodologies, find and resolve data discrepancies by using data cleaning methods and researching regulatory databases, customer data, etc.
• Support data integrity function by collecting, organizing and validating (via regulatory databases, customer questionnaire, etc.) the reliability of data from internal customers, literature, and analyses.

Inquiries Support

• Respond to internal and external product regulatory enquiries and requests; Respond to requests for technical information within a specified time frame so as to support company goals.
• Develop relationships with customer’s contacts to facilitate continued and improved business relationship.
• Act as a technical resource for internal customers such as Customer Service, Quality Control, Quality Assurance, and Operations departments.

QSHE Compliance

• Comply with the Quality, Safety, Health and Environment Policies
• Be aware and accustomed with the significant quality, safety/health, and environmental (QSHE) aspects/impacts associated with the work, including relevant legal/other requirements and emergency preparedness and response.

JOB REQUIREMENTS

Education

• Bachelor’s Degree in Chemistry, Government Affairs, Toxicology, Biology or Environmental.

Experience

• Minimum 3 years of product regulatory work experience.

Knowledge and skills

• Knowledge of product registration processes.
• Ability to effectively manage multiple projects.
• Working knowledge of Latin America product and/or chemical regulations.
• Knowledge of regulatory systems and database management.
• Knowledge of industry and regulatory requirements is preferred.
• Excellent organizational, communication and interpersonal skills.
• Ability to understand and clearly communicate complex, constantly evolving regulations verbally and in writing.
• Strong analytical skills.
• Strong computer skills with knowledge of MS Office.
• Understanding of components of appropriate business processes and internal systems.
• Strong attention to detail and documentation writing skills.

Other requirements

• Bilingual in English and Spanish is required.
• Good command of both oral and written Portuguese is beneficial.

* Relocation is not available for this role