Regulatory Affairs Strategist

hace 1 semana


Barcelona, Barcelona, España Galderma Pharma S.A A tiempo completo
Job Overview

We are seeking a highly skilled Regulatory Affairs Strategist to join our team at Galderma Pharma S.A. in Barcelona, Spain. As a key member of our global regulatory affairs team, you will be responsible for delivering innovative and breakthrough regulatory strategies for clinical trial registration with health authorities.

About the Role

The successful candidate will have experience with performing regulatory submissions in at least one key regulatory region and be able to communicate complex regulatory strategies to senior leadership teams. You will also have a strong understanding of regulatory requirements for pharmaceutical/biological product development and be able to interface effectively with regulatory agencies.

Main Responsibilities
  • Create and manage clinical trial regulatory strategy for biologics, ensuring accurate and compliant dossiers.
  • Execute clinical trial regulatory activities in alignment with agreed clinical timelines, including responses to health authority queries and amendments to clinical trial dossiers.
  • Manage health authority interaction for assigned regions in alignment with agreed regulatory strategy.
  • Identify and assess risks associated with clinical regulatory submissions and recommend strategies to mitigate these risks.
Requirements

To succeed in this role, you will need:

  • Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development.
  • Experience with performing regulatory submissions in at least one key regulatory region.
  • Excellent communication skills, with the ability to communicate complex regulatory strategies to senior leadership teams.
  • A strong understanding of regulatory requirements and procedures.
What We Offer

In return for your expertise, we offer a competitive salary of €80,000 per annum, plus benefits package that includes:

  • Annual performance-related bonus.
  • Pension scheme.
  • Flexible working hours and remote work options.


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