An international diagnostics company that is market leader in IVDs and biomarkers.
Main responsible for supporting regulatory submissions and maintenance of Business Licenses.
Supports labelling updates, registration of electronic version of Package Insert in PMDA website and maintenance of UDI in Medical Device Database.
Conducts monthly safety management information and maintains electronical submission system.
Supports GVP annual training and self-inspection as marketing authorization holder.
Supports to prepare required documents for periodic QMS certificate renewal and reimbursement updates for registered product.
Supports PMDA consultation
Supports preparation of marketing approval application of a new product and maintenance of the registered product in Japan.
【WHY YOU SHOULD APPLY】
The company offers competitive salary package
They are expanding in Therapeutic Areas soon
Fast career progression
Office is in Shinagawa, Tokyo
Work from home options available
At least 3 years of Regulatory Affairs experience in a therapeutics area/IVD/medical device.
Basic knowledge of Japanese Pharmaceutical regulatory environment and experience with registration procedures.
Ability to organize, review and submit regulatory submission to authorities such as PMDA, MHLW, and local health agency.
Experience and knowledge of drug safety.
Self-motivated, detail oriented, and able to prioritize and plan effectively
BS/MS/RN in related scientific field or equivalent.
Proficient in Microsoft Office Suite (Word, Outlook, Excel and PowerPoint).
Ability to work independently as well as in a team environment.
Business fluent in Japanese and English (speaking and writing)
【FOR FURTHER INFORMATION】
050 1742 5298