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Regulatory Documentation Manager
1 tydzień temu
TN Poland is a leading company dedicated to helping clients build stronger businesses. We are now seeking a talented Regulatory Affairs Coordinator to join our team.
The successful candidate will be responsible for ensuring the quality of regulatory documentation and submissions, working closely with stakeholders to achieve this goal.
Key Responsibilities:
- Ensuring the quality of regulatory documentation and submissions.
- Collaborating with stakeholders to achieve regulatory compliance.
- Providing guidance and support to junior staff in compiling regulatory documentation.
- Supporting other regulatory-related activities as needed by the business.
Requirements:
- 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.
- Strong knowledge of global regulatory processes within the pharmaceutical industry and submission publishing requirements.
- Excellent communication and organizational skills.
