募集要項
- 募集背景
- 増員
- 仕事内容
-
Responsibilities will include, but are not limited to, the following:
１．Work with regulatory team in Summit to implement plans for products for both investigational and marketed products
２．Participate in or lead the regulatory sub-team (project team) for assigned product(s)/project(s)
３．Prepare, lead and review major regulatory applications (eg. INDs, Briefing Documents, Orphan Drug Applications, Marketing Applications)
４．Participate in and/or lead regulatory interactions with MHLW/PMDA on assigned projects.
５．Participate or acts as regulatory representative on various cross-functional teams
６．Participate in cross-functional initiatives
７．Maintain and reinforces compliance with Company SOPs and Work practices
８．Provide input and comments on draft regulatory guidance
* Reports to Director, Regulatory (Director, Regulatory reports to Head of Clinical R&D Japan)
- 応募資格
-
- 必須
-
Skills/Knowledge Required:
１．Experience around 10 - 15 years
Experiences in oncology / hematology preferred
２．Pharmacist preferred
- 歓迎
- -
- 募集年齢(年齢制限理由)
- 32～47歳 経験・能力を考慮 （特定年齢層の特定職種の労働者が相当程度少ないため）
- フィットする人物像
- -
- 雇用形態
- 正社員
- 勤務地
- 東京都千代田区
- 勤務時間
- 9：00～18：00
- 年収・給与
- 年収： ～1300万円 経験・能力を考慮
- 待遇・福利厚生
- 社会保険完備
- 休日休暇
- 土、日、祝、年末年始、ほか
- 選考プロセス
- ※新しい情報を掲載しておりますが、万が一募集を締め切っている場合もございますので予めご了承下さい。
