Application data creation related business / Planning position
協和キリン株式会社
- TOEIC
- Bio-pharmaceutical products
- Pharmaceutical manufacturing
- CTD
- Quality approval
- Application data creation
- Bio-production technology
- Manufacturing/analysis technology
- Application business
- CMC expertise
- Pharmaceutical affairs expertise
- Application data writing
- OTC drugs
- Experience in application data writing
- ICH guidelines
- CTD Q point
-
Gunma
-
1,001 to 10,000
Company Info
The collaborative Kirin Group is engaged in the development of pharmaceutical products, and is committed to promoting health. We aim to realize a prosperous life, and seek non-smokers.Job Summary
In the business of applying for the quality approval data of bio-pharmaceutical products, work in English (partly in Japanese) such as writing and revising application data from the regulatory authorities, and work in a global environment. In addition, it is possible to participate in business activities that include overseas assignments, accumulating extensive experiences and knowledge, from the initial development phase to post-market application and maintenance.Duties
In the business of applying for the quality approval data of bio-pharmaceutical products, the following tasks are included. Writing and revising application data (focusing on CTD) in English (partly in Japanese), responding to inquiries from regulatory authorities, project management and various meetings with internal and external stakeholders (including participation in teleconferences and possible overseas business trips). In addition, it is necessary to have experience of at least 2 years in the business of pharmaceutical manufacturing or at least 1 year in the business of pharmaceutical manufacturing or pharmaceutical affairs, and to have experience in the application data writing.Login to see all information about offers.
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