Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
This position is responsible for coordinating import and export operations of regulated products and materials while ensuring compliance with customs, regulatory, and company quality requirements.
The role serves as a key liaison between regulatory authorities, customs brokers, logistics providers, and internal stakeholders to ensure the timely and compliant movement of products used in clinical research and other regulated activities.
A strong focus of this role is regulatory compliance, including support for submissions, permits, and interactions with health authorities such as COFEPRIS, while maintaining operational continuity and minimizing risks associated with international trade activities.
Coordinate and manage import and export operations for regulated products and materials.
Ensure compliance with customs regulations, health authority requirements, and company quality systems.
Act as the primary point of contact with customs brokers, carriers, freight forwarders, and regulatory agencies.
Support regulatory activities related to import/export permits, authorizations, and documentation, including interactions with COFEPRIS.
Monitor shipments and proactively resolve customs, regulatory, or documentation issues that may impact timelines.
Ensure proper tariff classification and regulatory classification of imported and exported products and materials.
Support comparator sourcing and procurement activities for clinical trials.
Maintain accurate records and documentation in accordance with GxP requirements.
Prepare operational and regulatory reports required by customers and internal stakeholders.
Support audits, inspections, and compliance-related activities associated with international trade operations.
Identify and mitigate regulatory and trade compliance risks that could impact business operations.
Experience in import/export operations within regulated industries such as pharmaceutical, biotechnology, medical devices, healthcare, or clinical research.
Knowledge of COFEPRIS requirements and regulatory processes related to international trade.
Understanding of customs regulations, trade compliance, and import/export documentation.
Experience working within GxP-regulated environments.
Strong stakeholder management and problem-solving skills.
Ability to coordinate multiple activities while maintaining compliance and operational efficiency.
