Regulatory Affairs Specialist

hace 4 días

Barcelona, Barcelona, España Galderma Pharma S.A A tiempo completo
{"title": "Regulatory Affairs Specialist", "description": "Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Galderma Pharma S.A. in Barcelona. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating CMC dossier sections for assigned products, contributing to global regulatory CMC strategies, and ensuring compliance with ICH, FDA, and EU guidelines.

Key Responsibilities
  • Contribute to global regulatory CMC strategies and assess the impact of proposed CMC changes.
  • Review data provided to support dossier preparation and identify gaps and risks.
  • Write and assemble CMC sections of regulatory submissions and develop project plans and schedules.
  • Ensure all CMC dossiers are stored in the company database and provide guidance on ICH, FDA, and EU CMC guidelines.
  • Develop and maintain excellent relationships with internal functional groups, contract manufacturing organizations, and other relevant partners.
Requirements
  • Effective experience in CMC Regulatory Affairs and background in the pharmaceutical industry.
  • Experience with topical and/or systemic drugs, including biologics and small molecules.
What We Offer

We offer a competitive compensation package with bonus structure and extended benefit package. You will have the opportunity to work in a hybrid work culture and participate in feedback loops to establish a personalized career path. Our company values diversity and inclusion and believes in empowering employees to grow and take on accountability.

Process Steps
  • Send your CV in English.
  • If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition.
  • The next step is a virtual conversation with the hiring manager.
  • The final step is a panel conversation with the extended team.
", "lang_code": "en-US"}

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