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Regulatory Affairs Coordinator

1 tydzień temu

Gdańsk, Pomerania, Polska TN Poland Pełny etat

At TN Poland, we are committed to excellence in regulatory affairs. Our ideal candidate will be responsible for ensuring the quality of regulatory documentation and submissions.

We offer a comprehensive training program to ensure success in this role and opportunities for professional development in an international environment.

Responsibilities:

  • Perform technical quality control of dossier documents and complex submissions to ensure compliance with both internal and external standards.
  • Collaborate with relevant stakeholders during the preparation and quality control of reports and regulatory documentation.
  • Act as the first-level support and guide junior staff in compiling regulatory documentation, ensuring that all quality targets are met and validation errors are resolved.
  • Provide additional support for other regulatory-related activities as needed by the business.

Requirements:

  • Previous experience in electronic submission publishing, dossier management, and the dispatch of regulatory dossiers across various regions.
  • Demonstrated experience in publishing complex and major submissions, including modules 3, 4, and 5.
  • Strong knowledge of global regulatory processes within the pharmaceutical industry and submission publishing requirements.
  • Proficiency with electronic document management systems and publishing tools, along with a deep understanding of document publishing.
  • Excellent verbal and written communication skills.
  • High level of organizational awareness and attention to detail.
  • Advanced level of English.