Regulatory Affairs Specialist

hace 2 meses


Barcelona, Barcelona, España Galderma A tiempo completo
Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Galderma. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating CMC dossier sections for assigned products.

Key Responsibilities:

  • Contribute to global regulatory CMC strategies
  • Assess regulatory impact of proposed CMC changes and contribute to CMC regulatory strategies
  • Review data provided to support dossier preparation and identify gaps and risks
  • Write and assemble CMC sections of regulatory submissions
  • Develop and maintain project plans and schedules for CMC submissions
  • Ensure all CMC dossiers are stored in the company database
  • 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
  • Share knowledge and experience with other team members

Requirements:

  • Effective experience in CMC Regulatory Affairs
  • Background in pharmaceutical industry
  • Experience with topical and/or systemic drugs (Biologics and/or Small Molecules)

What We Offer:

  • A competitive compensation package with bonus structure and extended benefit package
  • A hybrid work culture
  • Feedback loops and personalized career path
  • Ownership and accountability from day one


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