Regulatory Affairs Specialist
hace 3 semanas
We are committed to fostering an inclusive environment and promoting diversity in our business, teams, and culture.
As a world leader in plasma-derived medicines, we have a presence in over 100 countries and a global team of over 20,000 people.
We are seeking a Regulatory Affairs Specialist to join our team and contribute to our mission of leading the pharmaceutical industry.
Key Responsibilities- Prepare and submit registration and renewal dossiers for our products.
- Coordinate the preparation of technical documentation with R&D, manufacturing, and QA departments.
- Define regulatory requirements for our products and ensure compliance.
- Prepare and submit official responses to Health Authority questions.
- Review and assess regulatory impact for product or manufacturing changes.
- Adapt licenses to current regulations and manage product samples or labels.
- Review and approve technical documents to ensure coherence and compliance.
- Bachelor's Degree in Health Sciences or engineering.
- Experience working in R&D or technical departments.
- Advanced level of Spanish and English (C1) and of MS Office (Excel).
- Analytical skills, attention to detail, and ability to summarize and evaluate.
We offer a challenging and rewarding career in a critical function like Regulatory Affairs.
We'll help you grow professionally and provide a flexible schedule and benefits package.
Grifols is an equal opportunity employer and values diversity in our business, teams, and culture.
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