Jefe de Aseguramiento de Calidad (Regente)

About the role

The Quality Assurance Head (Regent) will ensure that the pharmaceutical distribution operation complies with all legal and regulatory requirements, following Good Practices for Storage and Distribution of Medicines and Medical Devices. This role guarantees that quality standards set by regulators and commercial partners are consistently met.

Key responsibilities

• Act as the pharmaceutical regent for the distributor before the Ministry of Health and other authorities.
• Schedule and manage biennial renewals of sanitary licenses for medicines, cosmetics, hygienic products, medical devices and food.
• Coordinate and accompany inspections by the Ministry of Health, both routine and license‑renewal audits.
• Communicate regulatory changes and facilitate their implementation.
• Submit the annual proposal for psychotropic drug quotas to the Ministry of Health.
• Obtain import permits for controlled substances and reference standards, ensuring uninterrupted supply.
• Prepare monthly reports on movements of controlled medicines and medical samples in compliance with law 292.
• Provide the authorized pharmacy list to the finance team to prevent sales to non‑authorized establishments.
• Handle special requests to the Ministry of Health and other entities to streamline import, storage and distribution processes.
• Ensure adherence to Good Practices for storage, distribution and transport of medical supplies.
• Manage pharmacovigilance activities required by local regulations.

Required profile

• Degree in Pharmacy, Pharmaceutical Sciences, or a related field.
• Extensive experience in regulatory affairs and quality assurance within a pharmaceutical distribution environment.
• Strong knowledge of national health regulations, sanitary licensing, and controlled substance management.
• Proven ability to interact with health authorities and manage compliance projects.

Required skills

• Regulatory compliance management
• Pharmacovigilance procedures
• License renewal processes
• Import permit coordination