パーソルキャリア株式会社(BilingualRecruitmentSolutions)

パーソルキャリア株式会社 (BilingualRecruitmentSolutions)

Regulatory Affairs - Dossier

求人会社名 : 会社名非公開

求人ID : Job-00044049

  • 語学(英語)を生かす
仕事内容 Dossiers for development products

* 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



Variation dossiers

* 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
応募資格 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
勤務地 東京都
Tokyo 23 wards
勤務時間 会社規定に準ずる
年収・給与 500万円~900万円
500万円~900万円

セールスポイント Regulatory role

求人会社概要

求人会社名 会社名非公開
概要 We provide information on medicines, vaccines and health maintenance to support the health of various animals.
業種 病院・医療機関

コンサルタントからのメッセージ

"詳細は下記までお気軽にお問合せ下さい。

Thomas Partridge
Senior Consultant
Pharmaceutical
Bilingual Recruitment Solutions
PERSOL CAREER CO., LTD.
Marunouchi Bldg. 27F-28F 2-4-1 Marunouchi
Chiyoda-ku Tokyo 100-6328
Tel: +81-3-6370-7942
thomas.partridge@persol.co.jp
http://igs.inte.co.jp/"

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