Quality Assurance and Compliance Officer

7 dni temu


Gdańsk, Pomerania, Polska TN Poland Pełny etat

Join us at TN Poland, where we value excellence in regulatory affairs. As a Regulatory Affairs Coordinator, you will play a crucial role in ensuring the quality of regulatory documentation and submissions.

We offer a dynamic work environment, opportunities for professional development, and a comprehensive training program to ensure success in this role.

Key Responsibilities:

  • Performing technical quality control of dossier documents and complex submissions to ensure compliance with internal and external standards.
  • Collaborating with relevant stakeholders during the preparation and quality control of reports and regulatory documentation.
  • Acting 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.
  • Providing 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.


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