Coordinador de Asuntos Regulatorios

About the role

SteinCares is looking for a Regulatory Affairs Coordinator to lead the regulatory strategy for launching pharmaceutical products across Central America and the Caribbean. The role bridges global drug development with regional health needs, ensuring timely approvals and compliance.

Key responsibilities

• Define and execute the regulatory strategy for submission and approval of health registrations for launch projects in the region.
• Conduct pre‑audits and full audits of registration dossiers for new products.
• Oversee the preparation and submission of sanitary registration files, identifying and escalating risks in line with launch timelines.
• Provide regulatory support to supply, sales, marketing, medical, and quality teams for both existing and innovative portfolio items.
• Maintain current registrations and ensure ongoing compliance of the product portfolio.

Required profile

• Licensed pharmacist registered with the Colegio de Farmacéuticos de Costa Rica.
• Minimum 5 years of solid regulatory experience handling bioequivalent, biologic, and biosimilar drug registrations in Central America and the Caribbean.
• Proven experience managing a team.
• In‑depth knowledge of Central American and Caribbean regulatory frameworks for synthetic products, biologics, and biosimilars.
• Fluent oral and written English.

Required skills

What we offer

• Hybrid work model with an indefinite permanent contract.
• Opportunity to shape regulatory strategy in a fast‑growing, multinational pharmaceutical company.
• Dynamic culture that values curiosity, ownership, and rapid impact.
• Access to professional development through the #SteinJourney program.