Freelancer profile translated to English.

Description

Pharmaceutical Biochemist with over 15 years of experience in regulatory affairs for agricultural inputs, fertilizers, and biological products. Specialized in registration management, preparation and review of technical dossiers, and regulatory compliance in Ecuador, the Andean Community, and Central America.

Industry field of expertise

Languages

Spanish
Native or bilingual
English
Conversational

Workplace preferences

Can work on-site

Quito (up to 20km)

INTEROC S.A.
REGULATORY AFFAIRS COORDINATOR
AGRICULTURE
February 2015 - December 2024 (9 years and 10 months)
Quito, Ecuador
•Managed registration, renewal, use extension, and maintenance processes for agricultural inputs before AGROCALIDAD and regional authorities.

•Supervised the technical and trademark documentation required for product commercialization in Ecuador and Central America.

•Managed technical interaction with regulatory authorities, addressing observations and regulatory requirements.

•Followed up on laboratory analyses, reviewed COAs and technical documentation for regulatory control.

•Coordinated with internal departments (quality, logistics, legal, and commercial) ensuring documentary coherence and regulatory compliance.

•Managed over 40 products in the agricultural portfolio, optimizing regulatory response times.
Technical dossier evaluation Stakeholder Management Regulatory Consulting Regulatory Strategy Schedule Tracking
GLOBALCHEM QUÍMICOS INDUSTRIALES Y AGRÍCOLAS
REGISTRATIONS AND TRADEMARKS ANALYST
AGRICULTURE
November 2025 - February 2026 (3 months)
Quito, Ecuador
•Managed sales registrations of agricultural inputs before AGROCALIDAD, ensuring compliance with current regulations in Ecuador.
•Prepared and followed up on technical and administrative files for product registrations, renewals, and updates.
•Coordinated the registration and maintenance of trademarks, including documentary control and trademark procedure tracking.
•Prepared letters of compatibility, technical documentation, and regulatory support required for commercial processes.
•Planned and tracked regulatory projects.
•Addressed observations and requirements issued by the regulatory authority.
•Reviewed technical information documentation (COA, SDS/MSDS, specifications, supporting studies) ensuring regulatory compliance.
•Provided regulatory support for operations in Ecuador and LATAM, aligning local requirements with regional guidelines.