Coordinador de Asuntos Regulatorios Regional

About the role

We are looking for a Regional Regulatory Affairs Coordinator to ensure the acquisition, maintenance and validity of health registrations for a wide range of products across multiple markets. The role guarantees strict compliance with local and international health regulations while optimizing technical and legal processes to enable timely market access.

Key responsibilities

• Analyze and interpret regulatory requirements for chemical drugs, biologics, bio‑equivalents, cosmetics, dietary supplements, natural and biomedical products.
• Prepare, assemble and continuously update technical dossiers required for health registrations.
• Submit and manage registration documentation with local health authorities, using official digital platforms such as REGISTRELO.
• Handle post‑registration activities including renewals, re‑inscriptions, and product modifications (formula, name, labeling, shelf‑life, etc.).
• Incorporate regulatory updates into master product files and approve final packaging and labeling artwork.
• Maintain up‑to‑date knowledge of national and international health legislation and ensure compliance at every regulatory stage.
• Coordinate specific institutional procedures such as pre‑qualification with the Costa Rican Social Security Fund (CCSS) and state control processes.

Required profile

• Pharmacy degree with professional registration.
• 3–5 years of experience in regulatory affairs within the pharmaceutical industry, handling regional registrations.
• Proven experience with the REGISTRELO platform and familiarity with Central American Technical Regulation (RTCA) and CCSS processes.

Required skills

• Regulatory dossier preparation and management.
• Use of REGISTRELO digital submission system.
• Knowledge of RTCA, CCSS and regional health ministry regulations.
• Product labeling and packaging approval.