Regulatory Operations Specialist — Hybrid & Flexible Hours

Grifols; Sant Cugat del Vallès; Hybrid; EUR 55,000 - 70,000; Full time

Benefits offered by this job

Hybrid Model

Job summary

Grifols is seeking an Immunohematology/Operations Regulatory Affairs Specialist to join the Diagnostic Regulatory Affairs team. You will prepare registration documents, coordinate global submissions, and provide regulatory guidance across R&D, manufacturing, and QA.

Strong analytical skills and fluency in Spanish and English are required, with a hybrid work model offered. The role focuses on adapting licenses to current regulations, responding to health authorities, and supporting commercial

Qualifications

• Bachelor's degree in Health Sciences or engineering.
• Experience in RRAA or technical pharma departments.
• Immunohematology experience is desirable.
• Analytical skills, attention to detail, ability to summarize/evaluate.
• Advanced level of Spanish and English (C1) and MS Office.

Responsibilities

• Prepare and send registration/renewal/variations dossiers for relevant products.
• Prepare technical documentation based on R&D inputs.
• Coordinate regulatory submissions with R&D, manufacturing and QA.
• Interpret and apply global regulatory requirements and standards.
• Prepare official responses to Health Authority questions.
• Review regulatory impact on product/manufacturing changes.
• Adapt licenses to current regulations.
• Coordinate delivery of product samples/labels for registrations/changes.
• Review and approve packaging material; write/manage SOPs.
• Review technical documents for regulatory coherence.
• Assist commercial teams with regulatory docs for tenders.

Skills

Spanish C1

English C1

MS Office

Analytical skills

Education

Bachelor's in Health Sciences/Engineering

Job description

Grifols is seeking an Immunohematology/Operations Regulatory Affairs Specialist to join the Diagnostic Regulatory Affairs team. You will prepare registration documents, coordinate global submissions, and provide regulatory guidance across R&D, manufacturing, and QA.

Strong analytical skills and fluency in Spanish and English are required, with a hybrid work model offered. The role focuses on adapting licenses to current regulations, responding to health authorities, and supporting commercial