Quality Assurance and Compliance Officer
7 dni temu
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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