医薬開発本部薬事部メンバー - 製薬会社

勤務地 Tokyo, Japan
職種 正社員
給与 ¥10000000.00 - ¥12000000.00 per annum
専門 ライフサイエンス・ヘルスケア・医療機器・製薬,
Sub-specialization 薬事,
お問合せ Yuichi Matsuda
参照 JO-1912-431415
see Yuichi's jobs

[Company Description]
Global Pharmaceutical Company

[Responsibilities]
医薬開発本部薬事部メンバー
Basic purpose 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 Performance 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 Performance 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 BI's internal procedures

3)Accountabilities
Improves quality of submission documents by regulatory review in his/her responsible R&D+M project(s)

Related Performance 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 Company for getting approval as early as possible in his/her responsible R&D+M project(s)

Related Performance 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 Company regulatory strategy

5)Accountabilities
Regulatory intelligence activity

Related Performance 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 Organizational Requirements
Knowledge of latest regulations related to drug development in Japan
Knowledge of DRA processes in BI (preferable)
Interfaces (eg. with other functions or business units / global and local interfaces)
GRA, CDMA, CTMD, PV, Marketing

[Requirements]
Bachelors Degree
in-house coaching skill
More than 5 years having handled new drug development
In activity in regulatory group of trade association

[Employment Type]
Full time

[Salary]
10-12M
(Experiences and skills will be considered)

[Location]
Tokyo

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