Summary

Responsible for submission document preparation concerning CMC parts of NDA, PCA (Partial Change Application) and NMC (Notification of Minor Change) according to the agreed timelines to get the approval in Japan.

With regard to Marketed Products, responsible for regulatory evaluation for change requests generated at manufacture sites etc. based on Japanese guidelines and notifications.

About The Role

About the Role

Key Responsibilities

Manage overall RA CMC Japan processes and resources and represent RA CMC Japan to ensure the major accountabilities for RA CMC Japan listed in 2 and later below (As a line manager)
Contribute to TRD-Japan sub 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
Support or Lead 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
Contribute to development and post market maintenance of new modalities/technologies (e.g. CG&T products, nucleic acid drugs, radioligand therapy, medical devices, etc.)
Provide robust regulatory strategies and CMC documents at development
Contribute to stable supply by making appropriate change controls
Lead regulatory intelligence and strengthen CMC regulatory expertise

(As a line manager)

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 or Lead divestment and pruning activities and third party customers for marketed products in line with business strategy

Ensure that a timely and effective communication and escalation process is communicated to and followed by all personnel in their respective area.

(As a line manager)
Advocate continuous improvement of quality. (As a line manager)
Ensure all activities of associates comply with company standards and local regulations. (As a line manager)
Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
100% timely delivery of all training requirements including compliance.

Essential Requirements


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

Experience/Professional Requirement

6-8 years or more experience in pharmaceutical industry.
Possess extensive and excellent technical, scientific and/or regulatory CMC knowledge in drug development and/or maintenance.
Experience in strategic and excellent interfacing with PMDA and MHLW regarding CMC area.
Experience in working in a global environment.
Address RA CMC related issues by leading/working across relevant line functions and implement action plans.
Train and mentor/coach RA CMC members concerning regulatory requirements and intelligence.
Demonstrated ability for innovative and big picture thinking.

Have the ability to participate in industry group activities as a representative of the Novartis Japan, and ex-press opinions positively and lead the industry's other members.

Discuss local regulatory strategies at global level in English.

English Skill

Fluent English as business language

Be aware of fake job advertisements and job offers

Novartis is aware of employment scams which make false use of our company name or leader's names to defraud job seekers.

Novartis does not make job offers without interview and never asks candidates for money.

All our current job openings are displayed here.

If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information.

偽の求人広告や採用オファーにご注意ください

ノバルティスでは、当社名や幹部の名前を不正に使用して求職者をだます「採用詐欺」が発生していることを認識しています。

ノバルティスでは、面接なしに採用オファーを出すことはなく、候補者に金銭を要求することも決してありません。

現在の求人情報はすべてこちらに掲載されています。詐欺の可能性がある求人広告や採用オファーに遭遇した場合は、返信したり、金銭や個人情報を送ったりしないよう強くおすすめします。

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

Join Our Novartis Network

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

Benefits And Rewards

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Commitment To Diversity And Inclusion

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

Accessibility And Accommodation

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- and let us know the nature of your request and your contact information.

Please include the job requisition number in your message.


ノバルティスでキャリアを築く魅力:
病気と向き合う人々やそのご家族を支えるには、革新的な科学だけでは不十分です。それには、あなたのような情熱と知性を持った仲間が必要です。

互いに協力し、支え合い、刺激し合うことで、患者さんの人生を変えるようなブレークスルーを生み出すことができます。さあ、一緒により明るい未来を創りませんか?


ノバルティス・タレントネットワーク:
今のノバルティスの募集職種がご希望に合わない場合でも、ぜひタレントコミュニティにご登録ください。あなたに合ったキャリアの機会が見つかり次第、いち早くご案内いたします。


福利厚生:
ノバルティスの福利厚生と報奨について必要な情報は、ノバルティスライフハンドブックに記載されています。


多様性と包括性へのコミットメント:
ノバルティスは患者さんや地域社会などに対して、包括的かつ優れた職場環境、および多様なチームを構築するよう取り組んでいます。


合理的配慮:
ノバルティスは障害を持つ個々人に対して、合理的配慮を提供し協働することをお約束します。健康状態や障害に関して、採用プロセスあるいは必須の職務を満たすために合理的配慮が必要な場合は midcareer- 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。

Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

Benefits and Rewards:
Read our handbook to learn about all the ways we'll help you thrive personally and professionally:
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