Job summary
| Job category | Technical (Sales / Design / Development / Production Control)／Development / Research / Experimentation / Project Manager |
|---|---|
| Industry | Health Care／ Other Health Care |
| Employment type | Uncategorized |
| Position level | Other |
| Number of openings | 1 |
| Desired entry time | - |
| Required language skill |
Japanese （Fluent） English （Conversation） |
| Foreign language competence | - |
| Working hours | Others |
| Welfares / Leave systems | |
| Assistance in visa application | - |
| Number of foreign employees | - |
Work details
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
About interview
Liaison
Regulatory Affairs members
RGF HR Agent
500 〜 800 ten thousand JPY
