RA Associate

Location Tokyo
Job type Permanent
Salary 5,000,000 - 8,000,000 JPY
Reference 34079

COMPANY OVERVIEW】

A global leader in developing and manufacturing diagnostic products.

【JOB RESPONSIBILITIES】

  • 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

【REQUIREMENTS】

  • 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+

【FOR FURTHER INFORMATION】

  • Click apply

OR

  • Contact Saloni:

saloni.dharne@cornerstone.jp