Regulatory Affairs Specialist

Roche is hiring a Regulatory Affairs Specialist in San Jose, Costa Rica. Level rates it ; you can apply on Roche.

Level's read on this job

Little AI ●○○○ is how Level rates this role: aI is not part of the work.
The posting mentions regulatory affairs, pharmaceutical regulations and compliance among its tools and skills.
Level classes it as a mid-level role.
Roche has 1,200+ other open roles on Level.
Posted within the past week.

AI in this role

Ensure regulatory compliance and product registrations for pharmaceutical products across Central America and the Caribbean.

regulatory-affairspharmaceutical-regulationscompliancelabeling

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Impacto sostenible

Nuestra responsabilidad va más allá de innovar. Contribuyes a soluciones que responden a los desafíos más urgentes de la salud mientras reducimos nuestro impacto en el planeta. Juntos construimos un entorno laboral más sano, una sociedad más justa y un futuro mejor para las próximas generaciones.

La Oportunidad

Garantizar el registro sanitario y actualizaciones de los productos Roche de manera pronta y oportuna ante las Autoridades Reguladoras de los diferentes países de Centroamérica, Caribe y Venezuela y trabajo conjunto con otras áreas de la organización con el fin de que la innovación llegue lo más rápidamente a los pacientes.

Responsabilidades

Ejecutar estrategias de registro innovadoras y basadas en riesgo para acelerar el acceso a nuevas moléculas, renovaciones, cambios post-registro y sitios de fabricación.
Garantizar el cumplimiento regulatorio del producto comercial despachado a la región, manteniendo actualizadas las bases de datos y sistemas de Roche.
Asegurar el alineamiento con estándares globales y normativas locales en todas las actividades regulatorias asignadas, así como en las herramientas y plataformas internas.
Liderar una comunicación proactiva y transversal con áreas clave para dar visibilidad del estatus regulatorio, proteger el suministro y agilizar trámites complejos.

Quién Eres

Título profesional en Licenciatura en Farmacia (PharmD) e incorporación activa al Colegio de Farmacéuticos de Costa Rica (COLFAR).
Mínimo 6 meses de trayectoria en áreas regulatorias y en la gestión de etiquetado en países de Centroamérica, el Caribe y Venezuela.
Mínimo 6 meses de experiencia interactuando con Autoridades Sanitarias, asociaciones de la industria y actores clave del sector.
Dominio de las regulaciones sanitarias y de etiquetado vigentes en la región de Centroamérica, Caribe y Venezuela.
Comprensión sólida y aplicación de las Buenas Prácticas de Manufactura, Almacenamiento, Distribución y Transporte para productos farmacéuticos.
Dominio avanzado del idioma español e inglés (oral y escrito).

Beneficios de reubicación, no disponibles para este puesto de trabajo.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

How we rate this

Regulatory Affairs Specialist at Roche rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.

Key facts

Regulatory Affairs Specialist is an open job at Roche.
Level rates this role AI Level 1 of 4: Little AI.
The role is based in San Jose, Costa Rica.
The job was posted on November 9, 2026.
Seniority: mid.
Applications are handled by Roche. Apply on Roche

Prepare for this job

Built from this posting and from similar jobs on Level.

Skills and AI tools this role asks for

Regulatory AffairsPharmaceutical RegulationsComplianceLabeling

Questions you could be asked

Tell me about a project where regulatory affairs was part of your work. What did you do?
Tell me about a project where pharmaceutical regulations was part of your work. What did you do?
Tell me about a project where compliance was part of your work. What did you do?
Tell me about a project where labeling was part of your work. What did you do?

Adapt your resume

List these exact terms on your resume: Regulatory Affairs, Pharmaceutical Regulations, Compliance, and Labeling. An applicant tracking system matches the wording, not the idea.
Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.

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