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 （日常会話レベル） |
| 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
【抜群の福利厚生】ヨーロッパ系製薬メーカー/グローバルランキング15位以内
Job Description
Purpose: Provide professional regulatory inputs into development plans for effective development planning, its implementation, submission of new drugs and smooth review, timely approval
Tasks:
1. Propose regulatory strategy of R&D+M project(s) to Group Manager
2. Lead regulatory discussion in his/her responsible R&D+M project(s)
3. Improve quality of submission documents by regulatory review in responsible R&D+M project(s)
4. Improve cycle time efficiency in gaining R&D+M project approval
5. Conduct regulatory intelligence activity
Requirements
Knowledge
- Knowledge of latest regulations related to drug development in Japan
- Knowledge of DRA processes in the company
- Proficiency in interfaces (eg. with other functions or business units / global and local interfaces) such as GRA, CDMA, CTMD, PV, Marketing
Degree / Education
Bachelor's Degree 学部卒
Special Work Experience
- More than 5 years having handled new drug development
- In activity in regulatory group of trade association
Language
- English: Business level
- Japanese: Native level
面接について
連絡先
Regulatory Affairs members
RGFタレントソリューションズ株式会社
500 〜 800 万円
