Randstad is a global leader in the HR services industry, specializing in recruitment, staffing, and outsourcing solutions across 39 countries. As one of the world's largest HR providers, the company operates at a massive scale, connecting millions of candidates with opportunities in sectors ranging from technology and engineering to healthcare and logistics.

In Spain, Randstad maintains one of the most extensive professional networks in the country, with a presence in nearly every major city. For international professionals, Randstad serves as a primary entry point into the Spanish labor market, offering specialized recruitment services through divisions like Randstad Technologies and Randstad Professionals, which frequently handle roles for multinational clients requiring English or other foreign languages.

Founded in 1960 by Frits Goldschmeding in the Netherlands, Randstad has grown from a small local operation into the world's largest HR service provider. The company expanded into Spain in the 1990s and has since solidified its position through major acquisitions like Vedior.

For international professionals

Operates a vast network of over 200 offices across Spain, providing local support in almost every province.
Features specialized divisions for IT, Engineering, and Life Sciences that are highly relevant for skilled international workers.
Acts as a primary recruiter for many Fortune 500 companies established in Spain.
Provides a wide variety of contract types, including permanent placements and long-term outsourcing projects.

Regulatory Affairs Expert

Randstad España

This job was originally posted in Spanish and automatically translated to English. You'll most likely need Spanish to apply.

Job Description

- National registration of new brands, line extensions, and indications.

- Maintenance of registered products (e.g., translations, variations, RMP, annual fees, educational materials, databases...).

- Keep product information duly updated, maintain repositories in good condition, and communicate changes in safety labeling according to internal communication procedures.

- Management of printed packaging materials.

- Regulatory support to internal stakeholders.

- Regulatory support for out-licensed products and follow-up with licensees.

- Interaction with the AEMPS and other relevant authorities, including access to AEMPS databases (RAEFAR, fractionation).

- Ensure compliance with training for the management of regulatory activities and company databases.

- Ensure compliance with all applicable regulations, guides, applicable international standards, and company quality guidelines.

- Regulatory intelligence (Gx and competitors, parallel imports).

- Preparation for divestments and registration reductions/withdrawals.

- Prepare and respond to internal/external surveys/requests for information for the products within their scope.

- Review of promotional material.

- Attendance at internal meetings when appropriate.

- Education: Bachelor's Degree in Pharmacy, Science, or related scientific disciplines. Postgraduate qualification will be valued.

- Experience: Minimum 2 years of experience as a Regulatory Affairs technician/associate.

- Knowledge: Experience interacting with the AEMPS and knowledge of its main platforms.

- Languages: Advanced English (fluent spoken and written).

- Contract duration: Temporary (6 months).

- Working day and Schedule: Full-time with flexible entry and exit times.

- Work modality: Hybrid model.

- Benefits: Subsidy for the dining/cafeteria service at the company facilities.

View original advert (Spanish)

- Registro nacional de nuevas marcas, extensiones de línea e indicaciones.

- Mantenimiento del producto registrado (por ejemplo: traducciones, variaciones, RMP, tasas anuales, materiales educativos, bases de datos...).

- Mantener la información del producto debidamente actualizada, mantener los repositorios en buen estado y comunicar los cambios en el etiquetado de seguridad según los procedimientos de comunicación interna.

- Gestión del material de acondicionamiento impreso (packaging).

- Soporte regulatorio a los stakeholders internos.

- Soporte regulatorio a productos con licencia (out-licensed) y seguimiento con los licenciatarios.

- Interacción con la AEMPS y otras autoridades relevantes, incluyendo el acceso a las bases de datos de la AEMPS (RAEFAR, fraccionamiento).

- Asegurar el cumplimiento de la formación para el manejo de las actividades regulatorias y las bases de datos de la compañía.

- Asegurar el cumplimiento de todas las regulaciones aplicables, guías, estándares internacionales aplicables y directrices de calidad de la compañía.

- Inteligencia regulatoria (Gx y competidores, importaciones paralelas).

- Preparación para desinversiones y reducciones/bajas de registro.

- Elaborar y dar respuesta a encuestas/solicitudes de información internas/externas para los productos bajo su alcance.

- Revisión de material promocional.

- Asistencia a reuniones internas cuando corresponda.

- Formación: Licenciatura o Grado en Farmacia, Ciencias o disciplinas científicas afines. Se valorará cualificación de postgrado.

- Experiencia: Mínimo 2 años de experiencia como técnico/asociado en Asuntos Regulatorios (Regulatory Affairs).

- Conocimientos: Experiencia interactuando con la AEMPS y conocimiento de sus plataformas principales.

- Idiomas: Inglés avanzado (fluido oral y escrito).

- Duración del contrato: Temporal (6 meses).

- Jornada y Horario: Jornada completa con flexibilidad horaria de entrada y salida.