Regulatory Affairs Specialist

hace 3 semanas


Barcelona, Barcelona, España Grifols A tiempo completo
Join Grifols as a Regulatory Affairs Specialist

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.
Requirements
  • 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.
What We Offer

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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