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Regulatory Affairs Specialist

2 tygodni temu

Gdańsk, Pomerania, Polska TN Poland Pełny etat
Job Description

About the Role:

We are seeking a highly skilled Regulatory Affairs Coordinator to join our team in Gdańsk. As a key member of our organization, you will be responsible for ensuring compliance with global regulatory processes within the pharmaceutical industry.

Key Responsibilities:

  • Support junior staff in compiling regulatory documentation, guaranteeing quality targets are met and validation errors are resolved.
  • Perform technical quality control of dossier documents and complex submissions to ensure compliance with internal and external standards.
  • Collaborate with stakeholders during report preparation and quality control of regulatory documentation.
  • Provide additional support for other regulatory-related activities as needed.

Requirements:

  • Previous experience in electronic submission publishing, dossier management, and 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.
  • Excellent communication skills.
  • High level of organizational awareness and attention to detail.
  • Advanced level of English.