仕事概要
| 職種 | 技術職（販売、設計、開発、生産管理）／生産管理、品質管理、施工管理、EHS、PMS |
|---|---|
| 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） |
| 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 which focus on speciality care area
Job Description
1.Preparation for new drug applications (NDA)
(1)Creation of application dossiers of quality part with CTD format and correspondence with the Japanese regulatory agency, PMDA.
(2)Evaluation of drug product candidates for developing in Japan, and build development strategies.
2.Regulatory compliance of commercial products
(1)Preparation for variation applications and correspondence with the PMDA.
(2)Documentation for minor change notification.
3.Works related to GMP
(1)Support of foreign manufacturing site accreditation applications
(2)Support of pre-approval GMP inspections to foreign manufacturing sites
4.Works related to investigational medicinal products (IMP)
(1)Importation of IMP for local clinical trials
(2)Out sourcing of 2nd packaging and labeling of IMP
Needs communication skill in English in order to communicate with the Global R&D and foreign manufacturing sites.
面接について
連絡先
CMC Specialist||CMCスペシャリスト
RGFタレントソリューションズ株式会社
800 〜 1200 万円
