Jobs › Companies › Roche › Regulatory Affairs Specialist

About this Regulatory Affairs Specialist role at Roche

Roche · Onsite · San Jose, Costa Rica
This job posting is in Spanish.

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.

Ready to apply to Roche?
Apply to Roche

About Roche

We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

See all jobs at Roche →

Similar jobs

Inspire Medical Systems Inc.
Sr. Regulatory Affairs Specialist
Inspire Medical Systems Inc.
⚡ Apply early Minneapolis, MN Onsite $11,000–$150,000
● New 👁 Seen ✓ Applied 7h ago
Regeneron
Manager CMC Regulatory Affairs, Cell & Gene Therapy
Regeneron
⚡ Apply early Warren Hybrid $108,000–$176,000
● New 👁 Seen ✓ Applied 11h ago
ICON plc
Regulatory affairs manager - (CTIS/Veeva/AI)
ICON plc
⚡ Apply early Poland, Warsaw Onsite
● New 👁 Seen ✓ Applied 11h ago
Enovis
Regulatory Affairs Sustaining Specialist
Enovis
⚡ Apply early Enovis India - Hyderabad Onsite
● New 👁 Seen ✓ Applied 21h ago
Philips
Regulatory Affairs Specialist
Philips
⚡ Apply early Jakarta (Java) Hybrid
● New 👁 Seen ✓ Applied 21h ago
PP
Associate Director, Regulatory Affairs, AD Promo
Praxis Precision Medicines, Inc.
⚡ Apply early United States - Remote · location restricted $200,000–$221,000
● New 👁 Seen ✓ Applied 1d ago
AB
Senior CMC Regulatory Affairs Manager
AbCellera
⚡ Apply early Montreal Onsite
● New 👁 Seen ✓ Applied 1d ago
AstraZeneca
Associate Director, CMC Regulatory Affairs (Cell & Gene Therapies)
AstraZeneca
⚡ Apply early US - Cambridge Kendall SQ - MA Hybrid $135,625–$203,437
● New 👁 Seen ✓ Applied 1d ago
Viatris
Senior Regulatory Affairs Manager - Central Regulatory Affairs (CRA), Europe
Viatris
⚡ Apply early Lisbon, Lisbon, Portugal Onsite
● New 👁 Seen ✓ Applied 1d ago

Sign up for suggestions tailored to the jobs you open and the searches you save.

More jobs at Roche

See all jobs at Roche →

Apply now
🤖

Whoa — hold up

JobsRadar was built for real people having a rough time in their job search — not for automated requests. You're clicking way too fast and you're now temporarily blocked.

Come back later. If you're genuinely job hunting, we've got your back — just act like a human.

Catch your next role the second it’s posted.

Create a free account and we’ll watch the boards for you — the instant a job matches your search, it lands in your inbox or Telegram. No digging, no refreshing.

Create free account

Free forever · takes 30 seconds · already have one?

Get an edge on your job hunt.

Join our Telegram channel for the stuff that helps you land the role — salary benchmarks, the weekly market pulse, and new-feature drops. No spam, just signal.

Join the channel — it's free