Regulatory Affairs Manager
Location: Mexico City
Industry: AGROCHEMICALS
Seniority Level: Manager
Modality: Hybrid
Position Overview:
We are seeking an experienced Regulatory Affairs Manager to lead the development and execution of regulatory strategies ensuring the full compliance of our product portfolio
You will act as the key liaison with health authorities such as COFEPRIS, SEMARNAT, SENASICA, and regulatory entities, facilitating agile, safe, and legally sound access of products to the market.
Key Responsibilities:
- Design and implement regulatory strategies for the registration, importation, and lifecycle management of agrochemical products.
- Coordinate the preparation and submission of dossiers for new registrations, renewals, modifications, and controlled product procedures before COFEPRIS and other agencies.
- Manage prior import permits.
- Ensure compliance with Mexican Official Standards.
- Oversee documentation processes, including import notices, labeling, certificates of analysis, and free sale certificates.
- Collaborate closely with quality, logistics, and customs teams to guarantee efficient product flow and regulatory alignment.
- Lead regulatory audits, manage responses, and ensure timely implementation of corrective actions.
- Develop and maintain the Quality Management System Manual, ensuring compliance with Good Manufacturing, Documentation, Storage, and Distribution Practices.
- Represent the company before regulatory bodies and participate in sectoral forums or working groups.
- Maintain up-to-date regulatory databases and lead training efforts for the internal regulatory team.
Required Profile:
Education:
- Bachelor’s degree in Chemistry, Biotechnology, or related fields.
- Preferred: Master’s or specialization in Regulatory Affairs, Foreign Trade, or Health Legislation.
Experience:
- Minimum 5–7 years in regulatory affairs within the agrochemical industry.
- Proven expertise in import procedures, prior permits, and customs regulation.
- Experience managing regulatory platforms (Digipris, VUCEM, ).
- Solid relationships with COFEPRIS, SSA, Customs.
Technical Knowledge:
- Comprehensive understanding of national health regulations
- Advanced English is essential; a second language is a strong asset.
Core Competencies:
- Strong technical and regulatory expertise.
- Leadership, strategic thinking, and decisive execution.
- Clear and assertive communication skills, both internally and with authorities.
- Risk management and problem-solving in complex regulatory scenarios.
- High standards of organization, precision, and ethical responsibility.
Tipo de puesto: Tiempo completo
Sueldo: $27,000.00 - $35,000.00 al mes
Beneficios:
- Opción a contrato indefinido
- Teléfono de la empresa
Lugar de trabajo: Empleo presencial
