A global leader in developing and manufacturing diagnostic products.
Ensure the regulatory submission project are completed on time and that related control files are maintained.
Support labelling updates, registration of electronic version of Package Inserts
Conduct monthly safety management checks
Support PMDA consultations
2+ years of Regulatory Affairs experience in a therapeutics area/IVD/medical device.
1-2 years of Safety experience in a therapeutics area/IVD/medical device preferred.
Basic knowledge of Japanese Pharmaceutical regulatory environment and experience with the relevant registration procedures
Business fluent in Japanese and English (speaking and writing) / TOIEC 730+
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