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.

This job was published 3 months ago

Regulatory Affairs Specialist

Randstad España

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

Job Description

Manage the preparation, submission, and maintenance of marketing authorizations for the company's products (medicines).
Generate and collect all internal and external information for the evaluation or maintenance of dossiers.
Follow up on dossiers submitted for registration to the corresponding authorities in each country, following the company's regulatory strategy.
Maintain and update registration dossiers (variations, five-year renewals, funding and price requests).
Provide support in bids and audits of potential licensors and licensees from a technical perspective (dossier quality, deadlines, procedures, etc.).
Maintain up-to-date knowledge of published and applicable regulations in the field of registration for all product categories, as well as provide support to the different departments involved.
Maintain the department's databases.

University degree in Health Sciences, ideally Pharmacy.
Postgraduate degree or Master's in Pharmaceutical Industry and/or Regulatory Affairs is highly valued.
Two years of previous experience in a Regulatory Affairs department carrying out registrations of medicines and medical devices.
Experience in generating technical documentation (Module 3, CMC, etc.) and different registration procedures (MRP, DCP, emerging markets, FDA, etc.) is especially valued.
High level of English.

Attractive compensation package
Flexible hours and extensive remote work
Flexible remuneration plan and social benefits

View original advert (Spanish)

Gestionar la preparación, presentación y mantenimiento de las autorizaciones de comercialización de los productos de la compañía (medicamentos).
Generar y recopilar toda la información interna y externa para la evaluación o mantenimiento de los dossiers.
Seguimiento de los dossiers presentados a registro ante las autoridades correspondientes en cada país siguiendo la estrategia regulatoria de la compañía.
Mantenimiento y actualización de los dossiers de registro (variaciones, revalidaciones quinquenales, solicitud de financiación y precio).
Dar soporte en las ofertas y auditorías de posibles licenciadores y licenciatarios, desde el punto de vista técnico (calidad del dossier, plazos, procedimientos, etc.).
Mantener un conocimiento actualizado de la normativa publicada y de aplicación en el ámbito de registros de todas las categorías de productos, así como prestar soporte a los diferentes departamentos implicados.
Mantener las bases de datos del departamento.