募集要項
- 募集背景
- An exciting biopharmaceutical company is looking to fill a Regulatory Affairs Manager position. The successful applicant will be responsible for sharing local and regional regulatory expertise to clinical development project teams.
- 仕事内容
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An exciting biopharmaceutical company is looking to fill a Regulatory Affairs Manager position.Responsibilities:
* Oversee the coordination and implementation of simple and complex submissions for products
* Find possible risks to strategic plans and suggest mitigation strategies
* Manage regulatory agency negotiations
* Ensure local and regional marketing approvals
* Develop innovative plans to work with local and regional regulatory agencies
* Develop strong business relationships with CROs and regulatory affairs consultancies
Requirements:
* Bachelor's degree or above in a scientific field
* 7+ years of regulatory affairs experience for the pharmaceutical sector
* Experience in both large and small companies is ideal
* Expertise in regulatory affairs
* Strong knowledge of drug development
* Written and spoken English and Japanese proficiency
- 応募資格
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- 必須
- 7+ years of regulatory affairs experience for the pharmaceutical sector
- 歓迎
- 英語力必要。その他は詳細からご確認ください。
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY11,500,000.00 - JPY14,000,000.00 per annum
- 休日休暇
- 完全週休2日制, 土日祝日休み, 有給休暇