Regulatory Affairs Specialist

hace 2 meses

Barcelona, Barcelona, España Galderma A tiempo completo

About the Role

We are seeking a highly skilled Regulatory Affairs Specialist - CMC to join our team at Galderma. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our CMC (Chemistry, Manufacturing, and Control) dossier sections for our assigned products.

Key Responsibilities

  • Contribute to the development of global regulatory CMC strategies to support the launch and maintenance of our products.
  • Assess the regulatory impact of proposed CMC changes and collaborate with cross-functional teams to implement effective solutions.
  • Review and validate data provided to support dossier preparation, identifying gaps and risks, and working with stakeholders to resolve them.
  • Write and assemble CMC sections of regulatory submissions, ensuring accuracy and compliance with relevant regulations.
  • Develop and maintain project plans and schedules for CMC submissions, ensuring timely and efficient delivery.
  • Ensure all CMC dossiers are stored in our company database, maintaining accurate and up-to-date records.
  • Provide guidance on ICH, FDA, and EU CMC guidelines, ensuring compliance and best practices.
  • Develop and maintain excellent relationships with internal functional groups, contract manufacturing organizations, and other relevant partners to ensure alignment of regulatory CMC strategies and successful accomplishment of regulatory goals.
  • Share knowledge and experience with other team members, contributing to the growth and development of our Regulatory Affairs team.
  • Collaborate with service providers contracted to support a project, as needed.

Requirements

  • Effective experience in CMC Regulatory Affairs, with a strong background in the pharmaceutical industry.
  • Experience with topical and/or systemic drugs (Biologics and/or Small Molecules).
  • Strong knowledge of ICH, FDA, and EU CMC guidelines, with the ability to apply this knowledge in a fast-paced environment.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams and external partners.
  • Strong analytical and problem-solving skills, with the ability to identify and resolve complex issues.

What We Offer

  • A competitive compensation package with a bonus structure and extended benefits.
  • A hybrid work culture that supports work-life balance and flexibility.
  • Opportunities for professional growth and development, with a focus on ownership and accountability.
  • A diverse and inclusive work environment that values and celebrates individual perspectives and experiences.

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