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Regulatory Affairs CMC Expert

hace 2 meses

Barcelona, Barcelona, España Galderma A tiempo completo

Position Overview

We are seeking a highly skilled professional in Regulatory Affairs to manage and enhance the CMC (Chemistry, Manufacturing and Control) documentation for designated products, including prescription and non-monograph over-the-counter medications.

This role involves the development of strategic regulatory CMC plans aimed at geographical expansion and post-approval CMC initiatives.

Core Responsibilities

- Contribute to the formulation of global regulatory CMC strategies.

- Evaluate the regulatory implications of proposed CMC modifications and assist in the development of regulatory strategies that facilitate the implementation of these changes.

- Review data submitted for dossier preparation; identify potential gaps and risks, collaborating with stakeholders to address them.

- Draft and compile CMC sections for regulatory submissions.

- Create and maintain project timelines and plans for CMC submissions.

- Ensure all CMC documentation is accurately stored within the company database.

- Provide expert guidance on ICH, FDA, and EU CMC regulations.

- Foster strong relationships with internal teams, contract manufacturing organizations, and other key partners to align regulatory CMC strategies and achieve regulatory objectives.

- Share expertise and insights with team members.

- Collaborate with external service providers engaged in project support, as necessary.

Required Skills & Qualifications

- Proven experience in CMC Regulatory Affairs.

- Strong background in the pharmaceutical sector.

- Familiarity with topical and/or systemic medications, including Biologics and Small Molecules.

Benefits

  • A commitment to diversity and inclusion, believing that varied perspectives lead to improved outcomes.
  • A competitive salary package, including bonuses and comprehensive benefits.
  • A flexible hybrid work environment.
  • Opportunities for personalized career development through feedback loops.
  • A chance to be part of a growing organization that empowers employees from day one, encouraging ownership and accountability.