募集要項
- 募集背景
- 新規雇用
- 仕事内容
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Regulatory Affairs Senior Manager, individual contributor roleGroup Purpose:
To provides leadership, expertise, and execution for the regulatory strategy to obtain and maintain clinical trial and marketing licenses for company molecules in Japan in alignment with local business priorities and global regulatory strategy. The group also obtains and maintains local pharmaceutical company licenses and foreign manufacturing accreditation.
Job Summary:
• Developing and executing the regulatory strategies and plans; providing strategic regulatory expertise for drug development; interfacing with regulatory authorities; aligning with key cross functional partners; integrating into company’s commercialization process; continuously improving business processes;
• May be assigned to multiple company products for product specific activities.
• Business level English language skills and strong interpersonal skills with ability to influence and engage.
• Work closely with Global Regulatory Lead to integrate Japan regulator strategy into Global regulatory strategy.
- 応募資格
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- 必須
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Knowledge And Skills
－ Ability to work in matrix environments including cross functional and global teams
－ Analytical skills to evaluate and interpret complex situations and problems
－ Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives
－ Understanding of regulatory activities and how they affect projects and processes
－ Ability to understand and communicate scientific and clinical information
－ Organizational, communication, and time management skills needed to manage multiple assignments and processes
－ Communication skills in English. Native level Japanese
－ Computer skills
Education / Experience
Basic
－ Bachelor’s degree and 15 years of directly related experience including around 10＋ years of experience in Regulatory Affairs
- 歓迎
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Preferred
Education / Experience
－ Advanced degree preferred
－ In－depth regulatory experience
－ Knowledge of Japan legislation and regulations relating to medicinal products
－ Knowledge of drug development Scientific/Technical Excellence
－ Teamwork
－ Communication skills both oral and written
－ Ability to understand and communicate scientific/clinical information
- 募集年齢(年齢制限理由)
- 定年退職年齢の上限 （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
- ～ 1300万円ベース給与 + 15％変動賞与 + LTI package
- 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
