Compliance and Submission Specialist
6 dni temu
We are seeking a highly skilled Regulatory Affairs Coordinator to join our team at TN Poland. The successful candidate will be responsible for managing the quality of regulatory documentation and submissions.
The position offers a comprehensive training program to ensure success in this role and opportunities for professional development in an international environment.
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.
- Providing guidance and support to junior staff in compiling regulatory documentation.
- Supporting other regulatory-related activities as needed by the business.
Essential Skills and Qualifications:
- Experience in electronic submission publishing, dossier management, and the dispatch of regulatory dossiers across various regions.
- Expertise in publishing complex and major submissions, including modules 3, 4, and 5.
- Knowledge of global regulatory processes within the pharmaceutical industry and submission publishing requirements.
- Proficiency in electronic document management systems and publishing tools.
- Strong communication and organizational skills.
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