Grifols is a integral healthcare company that has been working to improve the health and well‑being of people around the world since 1909. We are leaders in plasma‑derived medicines and transfusion medicine, operating in more than 110 countries. Diversity is valued and we are committed to equal employment opportunities.
Mission
We are looking for a Regulatory Affairs Specialist to join our Diagnostic Regulatory Affairs department. The role involves preparing technical documentation, submitting product registrations and renewals, managing variations dossiers, and responding to regulatory queries.
Responsibilities
- Prepare and submit registration, renewal and/or variation dossiers for relevant products.
- Prepare and send official responses to any health authority questions.
- Prepare, evaluate, and follow up on technical‑regulatory and registration documentation.
- Prepare and review supporting documentation, technical reports or specific documents in response to regulatory or technical queries within established timelines.
- Prepare and maintain department procedures and the required SOPs within the applicable regulatory scope.
- Update and maintain the Technical Dossier.
Qualifications
- 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 information.
- Advanced level of Spanish and English (C1) and proficiency in MS Office (Excel).
Accommodations
We believe in diverse talent and will remove any barriers that may hinder your participation. If you require adjustments in our selection process, please let us know when applying.
Benefits
Hybrid work model and flexible schedule: Monday‑Thursday 7‑10 to 16‑19 h and Friday 8‑15 h with flexible start time.
Permanent contract of employment.
Location
Sant Cugat del Vallès, Spain.
Grifols is an equal opportunity employer.
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