仕事概要
| 職種 | 技術職（販売、設計、開発、生産管理）／開発、研究、実験、プロジェクトマネージャー |
|---|---|
| 業種 | 医療／ その他医療 |
| 雇用形態 | 未分類 |
| ポジションレベル | その他 |
| 募集人数 | 1名 |
| 希望入社時期 | - |
| 必須語学力 |
日本語 （流暢に話せるレベル） 英語 （ビジネスレベル） |
| 活かせる語学 | - |
| 勤務時間 | その他 |
| 福利厚生・休暇 | |
| ビザ取得支援 | - |
| 外国人従業員 | - |
仕事詳細
Company Overview
Global Pharmaceutical Company
Job Description
・Creation of CMC-related materials for development and post-marketing maintenance and regulatory response
Target items: Chemical synthetic products, antibody drugs and regenerative medicine products, Medical Devise (combination products)
・RA CMC to cover all modalities such as small molecule, antibody , cell & gene therapeutic products, radiopharmaceutical and medical devices at both development and post market phases.
・Provide high quality and robust CMC regulatory strategies and documents to support business needs in development and post market maintenance.a.CTD module 3 in collaboration with global RegCMC
B. QOS (Module 2)
C. Application Form
Requirements
・ University Degree Or Equivalent (Preferred Education: Biochemistry, Genetic Engineering, Cell And Molecular Biology, Immunology, Chemical Synthesis, Analytical Chemistry)
・Fluent English As Business Language
・ Over 3 -years experience in CMC related business area
・Experience of development, manufacturing, analytical testing and / or CMC regulatory for biologics products such as antibody drugs Experience of research, development and / or manufacturing for regenerative medicine especially for cell and gene therapies.
面接について
連絡先
CMC RA Associate/Manager
RGFタレントソリューションズ株式会社
1000 〜 1300 万円
