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Regulatory Affairs Specialist

hace 2 meses

Barcelona, Barcelona, España Galderma A tiempo completo

About Galderma

Galderma is a leading dermatology company with a unique legacy in the field. With a presence in approximately 90 countries, we deliver innovative, science-based solutions that meet the needs of consumers and patients. Our focus is on advancing dermatology for every skin story.

Our Culture

We value employees who are passionate about making a meaningful impact. Our culture is built on teamwork, collaboration, and a commitment to excellence. We empower our employees to grow and develop their skills, while ensuring business needs are met.

Job Summary

We are seeking a Regulatory Affairs Strategist to join our team in Barcelona, Spain. As a key member of our Global Regulatory Affairs team, you will be responsible for delivering innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities.

Key Responsibilities

  • Creating and managing clinical trial regulatory strategy for biologics
  • Executing clinical trial regulatory activities in alignment with agreed clinical timelines, including responses to health authority queries, amendments to clinical trial dossiers, regulatory SUSAR reporting, or any other regulatory activities as needed
  • Oversight of clinical trial regulatory submissions, ensuring accurate and compliant dossiers

Requirements

We are looking for a highly skilled and experienced Regulatory Affairs Strategist to join our team. If you have a strong background in regulatory affairs and a passion for delivering innovative solutions, we encourage you to apply.