
Regulatory Affairs Specialist
1w1 week agoGrifols
Sant Cugat del Vallès, ES · Full-time · €40,000 – €55,000
About this role
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, operating in more than 110 countries. Join our Diagnostic Regulatory Affairs department as a Regulatory Affairs Specialist.
The role involves preparation of technical documentation, submission and follow-up of product registration, renewal, and variations dossiers. You will handle official responses to Health Authority questions and maintain the Technical Dossier. Responsibilities include preparing supporting documentation and technical reports within established timelines.
We believe that diversity adds value to our business, teams, and culture. We are committed to equal employment opportunities and fostering an inclusive environment where diversity makes us outstanding. Be part of a growing global team of over 20,000 people.
This is a brilliant opportunity to develop your professional career in an excellent working environment. Grifols fully recognizes its employees as major assets. Information about Grifols is available at www.grifols.com.
Requirements
- 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 MS Office (Excel)
Responsibilities
- Prepare and send registration, renewal, and changes/variations dossiers of relevant products
- Prepare and send official responses to Health Authority questions
- Prepare, evaluate, and follow-up technical-regulatory and registration documentation
- Prepare and review supporting documentation, technical reports, or specific documentation in response to regulatory or technical queries within established timelines
- Prepare and/or maintain department procedures and required SOPs within applicable regulatory scope
- Update and maintain the Technical Dossier
Benefits
- Develop professional careers in an excellent working environment
- Inclusive environment where diversity makes us outstanding
- Equal employment opportunities
- Support for adjustments in selection process if required
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