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新着求人 薬事  (YK-25)
募集職種 外資系製薬企業の 薬事部メンバー
その他の薬事の求人はこちら
勤務地 東京
会社概要 非公開
求人要件 【Basic purpos of the job】
Provides professional regulatory inputs into development plans for effective development planning, its implementation, submission of new drugs and smooth review, timely approval
1)Accountabilities
Proposes regulatory strategy of his/her responsible R&D+M project(s) to Group Manager
Related Performace Indicators
•Participates R&D+M project(s) as a DRA representative
•Prepares regulatory strategy for his/her responsible R&D+M project(s)
•Timely/properly discusses critical regulatory issues of his/her responsible R&D+M project(s) with Group Manager presenting their countermeasures
2)Accountabilities
Leads regulatory discussion in his/her responsible R&D+M project(s)
Related Performace Indicators •Participates R&D+M project(s) as a DRA representative
•Identifies regulatory issues in his/her project(s) with their countermeasures
•Provides regulatory inputs to Local Project Team members and also Global Team Member DRA
•Perform regulatory practice in compliance with local regulation as well as **’s internal procedures
3)Accountabilities
Improves quality of submission documents by regulatory review in his/her responsible R&D+M project(s)
Related Performace Indicators
•Participates R&D+M project(s)
•Reviews submission documents prepared by R&D+M project team
•Provides R&D+M project team with regulatory advice to improve documents in quality
4)Accountabilities
Shorten cycle time of replying questions from PMDA / MHLW within ** for getting approval as early as possible in his/her responsible Ramp;D+M project(s)
Related Performace Indicators
•Participates R&D+M project(s)
•Review replies to PMDA / MHLW in his/her responsible R&D+M project(s)
•Leads communication with PMDA / MHLW officers in line with ** regulatory strategy
5)Accountabilities
Regulatory intelligence activity
Related Performace Indicators
•Watches regulatory issues around his/her responsible R&D+M project(s) carefully
•Provides regulatory inputs to maximize values of R&D+M product(s)
Regulatory and / or Organisational Requirements
•Knowledge of latest regulations related to drug development in Japan
•Knowledge of DRA processes in ** (preferable)
Interfaces (eg. with other functions or business units / global andlocal interfaces)
GRA, CDMA, CTMD, PV, Marketing
必要要件 【Degree / Education】
Bacheloes Degree 学部卒
Special Skills
** Japan in-house coaching skill (** Japan 社内コーチングスキル)
【Special Work Experience】
•More than 5 years having handled new drug development
•In activity in regulatory group of trade association
年収 能力、経験を考慮の上、当社規程により優遇 
募集背景 非公開 
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