CMC薬事 - 製薬会社

Location: Tokyo, Japan
Job Type: 正社員
Salary ¥10000000.00 - ¥14000000.00 per annum
Specialization: ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産)
職種 薬事
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お問合せ Eureka Teramura
参照 JO-2012-451949
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※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

[Company Description]
外資系製薬会社

  • 神経・免疫分野を中心に製品を手掛けています
  • まだ治療法が見つかっていない疾患の治療薬の開発にも力を注いでいます
  • 規模が小さいため個人の裁量が高く、自分で考え工夫できます
  • 社会貢献が非常に高いです

[Responsibilities]
Responsible for Regulatory CMC life cycle management (LCM) for commercial products (Biologics, Antisense oligos and Small Molecules) for delivering our high quality products to Japanese patients; Regulatory management of global change control strategy for Japan, including change control assessment and execution, i.e. preparation of PCAs. MCNs tight relationships with global regulatory CMC team and/or Japan QAQC, Supply chain. Japanese new drug application submission support

These are executed under tight relationships with not only Global regulatory CMC team, but Japan QAQC and/or Supply Chain.

  • To prepare, submit/notify PCA/MCN at appropriate timing
  • To manage/respond against inquiry from PMDA and make answers with global regulatory CMC team under tight relationship for getting approval
  • To manage/assess global change control for commercial products under Japanese regulation and to create regulatory submission strategy
  • To compare/confirm between M1.2 ENG, JPN and/or actual from the point of RA-CMC's view
  • To prepare/submit GMP compliance inspection request/FMA application to PMDA under cooperation with Japan QAQC and global Reg CMC team
  • To prepare and deliver effective external presentations.
  • To support the expansion of our portfolio in Japan by supporting J-NDA submission activity and staying current with information about early phase drug development candidates of Japan portfolio.
  • To support Sales for providing the answer to the question from hospital/pharmacy about CMC-related matters.
  • To check/input to global Reg CMC/JPN PO&T team about Japanese regulation update

[Requirements]

  • More than 5yr experience and knowledge in CMC fields
  • Demonstrated experience for PCA/MCN and negotiations with PMDA

[Employment Type]
Full time

[Salary]
10M-14M yen
※Experiences and skills will be considered

[Location]
Tokyo


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