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]
- 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
- 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
- Maintain the contents in various databases to share Japan status on marketed products precisely and transparently with all the stakeholders
- 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
- Support divestment and pruning activities and third party customers for marketed products in line with business strategy
- Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
- 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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