Regulatory Affairs Manager

東京都 外資系企業 13,000,000¥ - 16,000,000¥ 外資系企業
  • In Vitro Diagnostic Medical Devices
  • Join the Market Leader

企業情報

Global In Vitro Diagnostic Medical Devices Company, leading in Asia-Pacific region and Japan.

職務内容

・ Strategic communication with PMDA / MHLW / MAFF

・ Support for planning / execution of clinical trial plans in Japan and overseas (including GCP)

・ Data analysis, summary and CSR creation

・ Communication with pharmaceutical companies, academia, KOLs, etc.

・ Communication with Global RACC

・ Preparation of regulatory approval application materials, inquiries until approval / subcommittees, etc. PMDA / MHLW / MAFF

Responding to requirements

・ Supports GCP / reliability survey

理想の人材

・ Experience in clinical development / regulatory approval application / reliability assurance work

・ Experience in planning / managing clinical trials or clinical trials, and creating protocols based on regulatory affairs strategies

・ IRB support experience in clinical trial facilities, clinical trial contract experience

・ Has knowledge of related laws and regulations (Pharmaceutical Machinery Law, ISO13485, GCP, Clinical Research Law, etc.)

・ Knowledge in molecular biology / gene analysis / oncology area

条件・待遇

Development of a growing business unit directly under APAC. Career opportunities on a truly global scale.

コンタクト
Dr. Philipp Berndt
求人番号
4180832
電話
+813 6832 8945

求人情報

職種
勤務地
雇用形態
担当コンサルタント
Dr. Philipp Berndt
担当コンサルタントの電話番号
+813 6832 8945
求人番号
4180832
企業タイプ