Regulatory Affairs Specialist

Grifols; Sant Cugat del Vallès; Híbrido; EUR 45.000 - 60.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid model

Flexible schedule

Permanent position

Sant Cugat location

Descripción de la vacante

Grifols is seeking an RRAA Specialist to prepare technical documentation, submit product registrations and renewals, and manage variations dossiers for medicinal products and medical devices.

You will review dossiers, monitor submission progress, coordinate translations, and stay current with regulatory requirements across the portfolio. The role is based in Sant Cugat del Vallès with a hybrid work model.

Formación

• Bachelor's degree in Health Sciences or engineering.
• Experience in RRAA or technical departments within the pharmaceutical industry.
• Advanced level of Spanish and English (C1) and proficiency in MS Office (Excel).

Responsabilidades

• Prepare, compile, and maintain registration dossiers and other regulatory documentation for medicinal products and medical devices within the assigned portfolio.
• Prepare, review, and submit regulatory documentation for new registrations, renewals, variations, and other regulatory procedures.
• Review and validate dossiers prepared by other team members, ensuring accuracy, quality, and regulatory compliance.
• Monitor the progress of regulatory submissions and registration procedures, liaising with regulatory authorities when required.
• Maintain up‑to‑date knowledge of current regulations and regulatory requirements applicable to medicinal products and medical devices, ensuring ongoing compliance.
• Coordinate the translation of regulatory documentation, ensuring accuracy, consistency, and compliance with local market requirements.
• Collaborate with cross‑functional teams and external partners to ensure timely and high‑quality regulatory submissions.

Conocimientos

Analytical skills

Attention to detail

Summarization

Educación

Bachelor's degree in Health Sciences or engineering

Herramientas

MS Excel

Descripción del empleo

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce, and market innovative medicines, solutions, and services in more than 110 countries and regions.

Mission

The RRAA Specialist will be responsible for the preparation of technical documentation, submission and following up of product registration and/or renewal, variations dossiers, as well as other regulatory documentation.

Responsibilities

• Prepare, compile, and maintain registration dossiers and other regulatory documentation for medicinal products and medical devices within the assigned portfolio.
• Prepare, review, and submit regulatory documentation for new registrations, renewals, variations, and other regulatory procedures.
• Review and validate dossiers prepared by other team members, ensuring accuracy, quality, and regulatory compliance.
• Monitor the progress of regulatory submissions and registration procedures, liaising with regulatory authorities when required.
• Maintain up‑to‑date knowledge of current regulations and regulatory requirements applicable to medicinal products and medical devices, ensuring ongoing compliance.
• Coordinate the translation of regulatory documentation, ensuring accuracy, consistency, and compliance with local market requirements.
• Collaborate with cross‑functional teams and external partners to ensure timely and high‑quality regulatory submissions.

Qualifications

• Bo thorn the necessary bachelor's degree in Health Sciences or engineering.
• Experience in RRAA or technical departments within the pharmaceutical industry.
• Analytical skills, attention to detail, and ability to summarize and evaluate.
• Advanced level of Spanish and English (C1) and proficiency in MS Office (Excel).

Benefits

• Hybrid Model: Flexible remote/on‑site schedule.
• Flexible schedule: Monday–Thursday 7–10 to 16–19h and Friday 8–15h.
• Permanent position.
• Location: Sant Cugat del Vallès, Spain.

We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please let us know. Grifols is an equal opportunity employer.