募集要項
- 募集背景
- A global healthcare products manufacturer is looking for a RA Manager, preferably with the pharmacist's license and solid experience in RA. This position is responsible for the overall management of the regulatory department and its members as well as license maintenance.
- 仕事内容
-
A global healthcare products manufacturer is looking for a RA Manager, preferably with the pharmacist's license and solid experience in RA.Responsibilities:
* Provide planning, leadership and regulatory expertise to global product development and regulatory teams
* Establish ongoing liaison with key opinion leaders, government officials, and ensure that significant developments in the field are identified and monitored
* Ensure that all adverse events are dealt with in accordance with company SOPs as well as JP regulation
* Ensure effective team communication throughout the Regulatory department through the application of suitable reporting systems and structures and the identification and provision of appropriate training
* Provide coaching to the Regulatory team members
* Maintain licensee status (Manufacturing and Marketing license, General wholesaler License etc.) and manage pharmacovigilance activities for regulated products
Requirements:
* Bachelor's degree in Pharmaceutical Science or a related discipline
* Experience in regulatory affairs in dynamic, fast-paced work environment
* Experience in the FMCG, consumer or pharmaceutical industry
* Proficiency in Microsoft Office application software
* Business level verbal and written proficiency in both English and Japanese
* Pharmacist license holders are preferred
- 応募資格
-
- 必須
- Experience in regulatory affairs in dynamic, fast-paced work environment
- 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
- JPY8,000,000.00 - JPY10,000,000.00 per annum
