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Pharmaceutical Regulatory Affairs Technician

Hybrid in Madrid·Full-time·Added 3 days ago

Randstad España

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Overview

Job details

Permanent contract
Full-time hours.
Hybrid
Office and home days — the ad has the split.

Requirements

Have the right to work in Spain
Randstad España doesn't mention sponsorship in the ad.
Work in English
English is required, per the ad.
Be near Madrid for hybrid days
No relocation package mentioned.
Have 4+ years of experience
Senior-level role.
University degree
“Licenciatura en ciencias (imprescindible) y master en RA (deseable)” — per the ad.

This job was automatically translated to English.

Pay & benefits

What you'll get

Interesting and challenging projects
Good team and good working environment
2 days per week of teleworking
Be part of a leading company in the sector
Job stability

Requirements

What we're looking for

Bachelor's degree in science (essential) and Master's in RA (desirable)
At least 4 years of experience in RA because we are looking for a senior profile
Expert in CMC and high knowledge of regulations and guidelines
Solid project management skills
Rigor and attention to detail.
Capacity for technical analysis and synthesis
Organization and time management.
Teamwork and interdepartmental communication
Result orientation and regulatory compliance
High level of English as it is the working language

The role

From the Life Sciences team at Randstad Professionals, we are looking for a Regulatory Affairs Technician.

What you'll do

Compile documentation and draft dossiers for USA, EU, and rest-of-world (ROW)
Management of European procedures (national, DCP, MRP), USA (ANDA, First to file), and ROW
Manage the adaptation of dossiers for out-licensing
Manage due diligence and deficiency letters
Draft and manage variations and renewals
Maintain the database up to date
Participate in the change control system and advise on the regulatory impact of changes
Interact with different departments, clients, providers, etc.
Provide regulatory support to different departments

Hiring process

2 steps1 interview

Inscripción en la oferta
En revisión · With a consultor/a de Randstad
Preseleccionado
Contacto del consultor/a
With a consultor/a de Randstad
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Gestión final de la empresa
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Las fases finales las define la empresa cliente: la gestión final de los perfiles y la decisión de a quién contactar dependen exclusivamente de la empresa.
Randstad no publica plazos; el estado de la candidatura puede no cambiar por el alto volumen de inscripciones o porque la empresa gestiona sus propios tiempos.
Los estados publicados llegan solo hasta la preselección: Randstad no detalla entrevistas ni pruebas posteriores.

About Randstad España

Randstad España is the Spanish branch of Randstad N.V., a global leader in human resources and staffing solutions. The company provides a wide range of workforce solutions, including temporary and permanent placement, recruitment process outsourcing, and HR consulting. With a strong presence in Spain, Randstad España connects thousands of professionals with job opportunities across various sectors, including industrial, technical, and customer service roles.

For international professionals, Randstad España offers a gateway to the Spanish job market, with numerous openings in technical maintenance, customer service, and administrative roles. The company values diversity and inclusion, and its extensive network of offices across Spain ensures support for candidates seeking employment in different regions. Randstad's global reach and local expertise make it a reliable partner for those looking to relocate and work in Spain.

Industry: Staffing
Website: randstad.es

All open roles at Randstad España