Product Regulatory Affairs Analyst

Omya; Santa Catarina; Presencial; MXN 420.000 - 700.000; Jornada completa

Descripción de la vacante

Omya is seeking a Regulatory Affairs professional to support product registrations and ensure documentation complies with customer and regulatory requirements across markets.

The role involves coordinating with innovation teams in Latin America, preparing submissions, and maintaining data integrity in regulatory databases, while ensuring timely and accurate technical information for internal and external stakeholders.

Formación

• Bachelor’s Degree as listed.
• Minimum 3 years of regulatory work experience.
• Bilingual in English and Spanish is required.
• Good command of Portuguese is beneficial.
• Knowledge of product registration processes.
• Ability to manage multiple projects and data.
• Experience with regulatory systems and databases.

Responsabilidades

• Support regulatory assessment and registration to statutory regulations.
• Prepare product information and technical documentation.
• Coordinate submissions and license variations/renewals.
• Ensure compliance with customer requirements and industry standards.
• Respond to regulatory inquiries and maintain data integrity.
• Collaborate with Sales, QA, and Operations as a technical resource.
• Ensure translations meet local requirements and SDS content is correct.

Conocimientos

Product registration knowledge

Project management

Latin America regulations

Regulatory databases

Regulatory systems

Documentation writing

Detail oriented

MS Office proficiency

Educación

Bachelor’s degree in Chemistry / Government Affairs / Toxicology / Biology / Environment

Herramientas

MS Office

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