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Regulatory Affairs CMC Specialist

hace 2 meses

Madrid, Madrid, España Galderma A tiempo completo
About the Role

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

Key Responsibilities
  • Contribute to global regulatory CMC strategies and assess the regulatory impact of proposed CMC changes.
  • Review data provided to support dossier preparation, identify gaps and risks, and work with stakeholders to resolve them.
  • Write and assemble CMC sections of regulatory submissions, develop and maintain project plans and schedules for CMC submissions, and ensure all CMC dossiers are stored in the company database.
  • Provide guidance on ICH, FDA, and EU CMC guidelines and develop and maintain excellent relationships with internal functional groups, contract manufacturing organizations, and other relevant partners.
  • Share knowledge and experience with other team members and collaborate with service providers contracted to support a project, if appropriate.
Requirements
  • Effective experience in CMC Regulatory Affairs.
  • Background in the 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 that allows for flexibility and work-life balance.
  • Opportunities for professional development and growth within the company.
  • A dynamic and inclusive work environment that values diversity and promotes a culture of ownership and accountability.