募集要項
- 募集背景
- 新規雇用
- 仕事内容
-
Development Regulatory Affairs Manager, individual contributor roleGroup Purpose:
Facilitate patient access to company products in Japan through executing the development and regulatory plans; providing strategic regulatory expertise for drug development; interfacing with agencies on regulators; aligning with key cross－functional partners; integrating into the company’s commercialization process, and continuously improving our processes and developing our talent.
Job Summary:
－ Conducts regulatory activities for company products in Japan
－ Support drug development or commercialization activities in Japan based on the regulatory and submission strategy by serving as Japan Regulatory Lead （JRL）
－ Develop and maintains good relationship with Japanese Health Authorities to facilitate drug approvals.
－ Provide regulatory guidance and supports various internal teams by involving Japan Development Team and Global Regulatory Team.
- 応募資格
-
- 必須
-
Knowledge And Skills
－ Over 10 years experiences in pharmaceutical industry including at least 5 years experiences in regulatory affairs with experiences conducting PMDA consultations and CTN submission in Japan.
－ Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
－ Independently develops solutions that are thorough, practical and consistent with functional objectives
－ Ability to understand scientific/clinical information
－ Organizational, communication and time management skills needed to manage multiple assignments and processes
－ Communication skills in English
－ Native level Japanese
－ Computer skills
－ Bachelors in scientific discipline
- 歓迎
-
Preferred
－ More than 5 years experiences in development regulatory affairs working on oncology/hematology drugs.
－ TOEIC score ≥780, desirable
－ Advanced degree preferred.
- 募集年齢(年齢制限理由)
- 定年退職年齢の上限の為 （定年年齢を上限として募集するため）
- 雇用形態
- 正社員
- 勤務地
- 関東、関西
- 年収・給与
- ～ 1100万円ベース給与 + 15％変動賞与
- 選考プロセス
-
面接2回（通常な場合）
一回目：日本メンバー
二回目：グローバルダイレクト報告先
