Manager, RA CMC Manager Japan

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.

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。

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.

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。

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.

ノバルティスの製品は約8億人以上の患者さんに世界中で届けられています。

約10万の社員が世界中のノバルティスで働いており、その国籍は約147カ国に及びます。

ノバルティスファーマ株式会社は、スイス・バーゼル市に本拠を置く医薬品のグローバルリーディングカンパニー、ノバルティスの日本法人です。ノバルティスは、より充実したすこやかな毎日のために、これからの医薬品と医療の未来を描いています。詳細はホームページをご覧ください。https://www.novartis.co.jp

Japan

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to midcareer.japan@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

ノバルティスは障害を持つ個人と協力し、合理的配慮を提供することをお約束します。

健康状態や障害を理由に採用プロセスのいかなる部分においても、あるいは職務の必須事項を果たすために合理的配慮が必要な場合は midcareer-r.japan@novartis.com宛てに電子メールをお送りください。その際ご依頼内容、ご連絡先、求人票の番号を明記してください。