Apr 17, 2022

Job Description

RA CMCは、CMCに係るサイエンスや薬事の知識に基づき、NPKKのすべての開発品および市販品を、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。新しい医薬品や治療を患者さんのもとへできるだけ早く届けるとともに、それらの製品を安定的 に提供し続けるNPKK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。

RA CMCは低分子化合物や抗体医薬品等の既存のmodalityのグローバル同時申請や市販後変更管理対応に加え、近年は細胞治療や遺伝子治療といった 新しいModalityや放射性医薬品の開発などに幅広く対応しています。さらに承認取得後は市販後変更管理にも対応しており、すべてのmodality の製品に係わり続けることができるチャレンジングで成長の機会が得られる組織です。 CMC薬事の実務経験がある方はもちろん、CMC薬事未経験の方でも医薬品や再生医療等製品のCMC開発や製造・品質の専門知識や実務経験がある方に活 躍の機会があります。 前例や経験のない困難な状況でも、国内外の関連各部署と連携しながら前向きに業務に取り組める方にとっては、やりがいのある業務です。

Your responsibilities include, but not limited to:

1. Contribute to Japan sub team for project development and submission
- Lead or manage 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.

Why consider Novartis?
817million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Education, Work experience and Competency:
• 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 regulatory affairs CMC or a related pharmaceutical field.
• 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.
• It would be more preferable if there is work experience in development/submission or post-approval change control of radiopharmaceuticals

English Skill:
• Fluent English as business language (including English communication skill)
Global Drug Development
Research & Development
Full Time
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Manager, RA CMC Manager Japan

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