CMC薬事マネージャー - 製薬企業

勤務地 Tokyo, Japan
職種 正社員
給与 ¥11000000.00 - ¥13000000.00 per annum
専門 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）,
Sub-specialization 薬事,
お問合せ Yuichi Matsuda
参照 JO-2103-456995
about Yuichi Matsuda

Note: Fluent ~ Native level Japanese required

[事業内容・会社の特徴]
大手外資系製薬企業

[仕事内容]

  1. Contribute to the team for project development and submission
    • Make the input into development strategy from regulatory CMC perspective
    • Provide and/or manage CMC documents during project development
    • Prepare submission documents (CTD document and Application Form) in line with the agreed timeline
    • Prepare answer for PMDA inquiry working closely with relevant line functions
  2. Lead and implement Change Control Management for marketed product
    • Provide accurate regulatory evaluation for change request generated at manufacture site and elaborate submission strategy and timeline with relevant line functions
    • Prepare Application Form and necessary submission document in collaboration with global RA CMC and submit
    • Manage communication with Japan Health authority and prepare quality answer for PMDA inquiry after PCA submission to get approval timely
  3. Maintain the contents in various databases to share Japan status on marketed products precisely and transparently with all the stakeholders
  4. Maintain latest CMC regulatory intelligence in Japan and inform global RA CMC and other relating members timely and appropriately. Ensure regulatory compliance for all RA CMC deliverables
  5. Support divestment and pruning activities and third party customers for marketed products in line with business strategy
  6. Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
  7. 100% timely delivery of all training requirements including compliance.

※RA CMCは、CMCに係るサイエンスや薬事の知識に基づき、すべての開発品および市販後製品を、開発段階から製品ライフサイクルの終了までカバー しています。また、CMC薬事に関して、規制当局と直接交渉を行います。新しい治療を患者さんのもとへできるだけ早くお届けし、それらの製品を安定的 に提供し続ける企業のミッションにCMCの立場からdirectに貢献する役割を担っています。

[応募資格]
Education:

  • Degree in pharmacy, science, agriculture, technical and pharmaceutical engineering discipline required and more advanced degree preferable.

Experience/Professional requirement:

  • 3 years or more experience in pharmaceutical industry.
  • Possess extensive technical, scientific and/or regulatory CMC knowledge in drug development and/or maintenance.
  • Experience in interfacing with PMDA and MHLW regarding CMC area.
  • Experience in working in a global environment.
  • Address RA CMC related issues across relevant line functions and implement action plans.
  • Train RA CMC members concerning regulatory requirements and intelligence.

English Skill:

  • Fluent English as business language

[雇用形態]
正社員

[勤務地]
東京

[給与]
1100~1300万円

[待遇・福利厚生]
社会保険完備

[休日休暇]
完全週休二日制（土曜、日曜、祝日）、年末年始休暇、年次有給休暇

[選考プロセス]
書類選考、面接数回を予定

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