募集要項
- 募集背景
- 新規雇用
- 仕事内容
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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
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- 必須
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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
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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
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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