募集要項
- 募集背景
- A multinational pharmaceutical company is searching for an experienced Regulatory Affairs Manager. In this role you will lead communication with regulatory authorities, provide regulatory support to clinical development, manage the preparation of new drug applications (NDA), and provide regulatory support to obtain appropriate drug pricing.
- 仕事内容
-
A multinational pharmaceutical company is searching for an experienced Regulatory Affairs Manager.Responsibilities:
* Provide regulatory support for clinical development based on Japanese regulatory requirements
* Manage the regulatory consultation process and communicate between HQ and the Japan branch
* Coordinate the overall preparation for NDA dossiers, submission, and communication with regulatory authorities
* Maintain wholesaler and manufacture licenses as well as foreign accreditations of overseas manufacturers
* Provide regulatory training and consultation to employees
Requirements:
* Bachelor's degree in Pharmacy, Chemistry, or a scientific discipline
* Approximately 10 years' experience at global pharmaceutical companies
* 5+ years' license maintenance experience preferred
* Experience with PMDA consultation, clinical trial plan notification, new drug applications, and post-NDA GCP audits
* Verbal and written English proficiency
- 応募資格
-
- 必須
- Approximately 10 years' experience at global pharmaceutical companies
- 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
- JPY7,000,000.00 - JPY10,000,000.00 per annum
- 休日休暇
- 完全週休2日制, 土日祝日休み, 有給休暇
