Improve the Future of Healthcare with Grifols
We are a global healthcare company that has been working to enhance the lives of millions since 1909. Our innovative medicines, solutions, and services span over 110 countries and regions.
About Diversity and Inclusion
We believe that diversity adds value to our business, teams, and culture. We commit to equal employment opportunities that foster an inclusive environment.
About the Job
We seek a Nucleic Acid Testing (NAT) Regulatory Affairs Specialist for the Diagnostic Regulatory Affairs department.
Key Responsibilities:
* Prepare registration, renewal, or changes/dossiers for relevant products.
* Create technical documentation based on R&D inputs.
* Coordinate regulatory submissions with R&D, manufacturing, and QA departments.
* Define product regulatory requirements.
* Respond to Health Authority questions.
* Evaluate regulatory impact for product or manufacturing changes.
* Update licenses according to current regulations.
* Manage product samples or labels related to registration/renewal/change processes.
* Review and approve packaging material.
* Develop and manage SOPs.
* Verify technical documents for coherence and compliance with regulatory requirements.
Requirements:
* Bachelor's Degree in Health Sciences or engineering.
* Experience in RRAA or technical/R&D departments within the pharmaceutical industry.
* Scientific background.
* Advanced level of Spanish and English (C1), and MS Office (Excel).
* Analytical skills, attention to detail, ability to summarize, and evaluate.
What We Offer:
A brilliant opportunity to grow your career in a dynamic work environment. We prioritize employee development and well-being.
We offer a hybrid model schedule: Monday-Thursday 7-10 am to 4-7 pm, Friday 8 am-3 pm. A permanent contract position is available.