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)

Manager/Sr Manager CMC

求人会社名 : 会社名非公開

求人ID : Job-00045955

  • 語学(英語)を生かす
仕事内容 Responsibilities:

Responsibilities will include, but are not limited to, the following:

1 Assist in the review and coordination of Chemistry, Manufacturing and Controls (CMC) documentation for CTN, NDA/sNDA(including MCN), Drug Master Files(DMFs), CTD and MBL regulatory filings as assigned.
2 Raise with relevant line functions to ensure CMC documentation meets health authority regulatory CMC requirements and is in alignment with global regulatory CMC strategy.
3 Review and coordinate preparation of CMC section of CTN and NDA/sNDA annual reports as assigned.
4 Coordinate CMC documentation/information to satisfy local regulatory requirements for the release of clinical supplies and/or marketed product.
5 Assist in the development of internal guidelines for the preparation and maintenance of regulatory submissions.
6 Review and assess global regulatory impact of CMC changes relating to regulatory filings (change control).
7 Evaluate regulatory impact of GMP compliance and validation issues.
応募資格 Skills/Knowledge Required:
Bachelors degree in scientific discipline. Advanced degree desirable.
2 - 5 years pharmaceutical industry experience, prior laboratory or manufacturing experience a plus. Pr
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 1000万円~1500万円
セールスポイント Oncology specialized company

求人会社概要

求人会社名 会社名非公開
概要 This company strives to deliver highly innovative and life-altering drugs for our patients. The vision is is to construct a major global biopharmaceutical organization which concentrates on the discovery, the development, and the marketing of products for oncology and the treatment of other severe and immune conditions.
業種 医療機器

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。

Koto Ikeda
Consultant
Pharmaceutical
Bilingual Recruitment Solutions
PERSOL CAREER CO., LTD.
Marunouchi Bldg. 27F-28F 2-4-1 Marunouchi
Chiyoda-ku Tokyo 100-6328
Tel: +81-3-6370-7460
Dir: +81-3-6370-8015
koto.ikeda@persol.co.jp
http://igs.inte.co.jp"

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