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Job ad: Regulatory Affairs Manager
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Regulatory Affairs Manager
You will have a broad area of responsibility within quality assurance, pharmacovigilance, regulatory affairs and medical information and report to our Nordic Head of Scientific Affairs. The responsibilities could for some areas include all Nordic countries, as we are presently integrating our Nordic operations.
The primary responsibilities
- Quality assurance including production of various types of documentation (standard operating procedures, enclosures, work instructions etc.), self-inspections, participation in audits and follow up
- Reporting of adverse events, (SCP)
- National documentation of EU processes and translations of documents
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