Regulatory Affairs Specialist

hace 3 días

Barcelona, Barcelona, España Galderma A tiempo completo
Job Title: Regulatory Affairs CMC Specialist

Galderma is seeking a highly skilled Regulatory Affairs CMC Specialist to join our team. 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 and assess the 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, 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 as needed.
Requirements:
  • Effective experience in CMC Regulatory Affairs, background in the pharmaceutical industry, and 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 growth and development, including feedback loops and personalized career paths.
  • A growing company that values ownership, accountability, and diversity and inclusion.
Process Steps:
  • Send your CV in English.
  • Participate in a virtual conversation with Talent Acquisition, followed by a virtual conversation with the hiring manager, and a panel conversation with the extended team.

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