動物薬における薬事スペシャリスト/薬事 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2017年 11月 17日

求人情報

薬事

求人管理No.011537

会社概要

動物薬における薬事スペシャリスト

Preparation of dossiers for development of biological products in line with Japanese regulations, standards and MAFF expectations

募集要項

・Check registration files from GRaffrs for compliance with Japanese minimum requirements, identify gaps and work with GRaffrs and local CORA team to generate missing data
・Use subject reports from researchers for preparation of summaries suitable to be included into local registration files
・Complete local registration files with information not covered by original files from GRafrs.
・Prepare final versions of registration files and submit to MAFF in line with development plans.
・Participate in hearings and sub-committees, prepare material to explain and justify contents of the registration file
・Keep close contact with relevant partners at GRafrs to be informed at early stage about possible or decided variations.
・Check feasibility, required MAFF information and time/resources to amend existing local registrations.
・Prepare variation dossiers by compiling data from GRafrs and locally prepared additional data.
・Submit variation dossiers to MAFF.
・Notify minor change

募集条件

  • ・Scientific degree (Master or equivalent) in biology or medical sciences, Veterinarian preferred
    ・Minimum 2 years of experience in Animal Health industry or in Regulatory affairs in human health, animal health or food sciences industry
    ・Good communication and scientific writing skills
    ・Proficient in reading and writing scientific documents in Japanese and in English; able to understand and speak at proficiency level English

勤務開始日

  • 応相談

雇用形態

  • 正社員

勤務地

  • 東京

転勤有無

  • 当面なし