About the Role

　　Novartisを支える、Labeling manager募集!

　　人々の健康に貢献したい、そんな想いに共感するあなたへ。

　　「最も必要とされ信頼される製薬企業となる」ためには、革新的な製品を提供し、かつ、正確で分かりやすい情報を提供することが重要です。

　　私たちRA Labelingは、医薬品• 再生医療等製品の添付文書、包装資材の作成• 管理を行っており、医療関係者が見やすい資材を提供することで、患者さんの安全確保と適正使用推進に貢献しています。添付文書は医薬品• 再生医療等製品を正しく適切に使用する際の基本となる最も重要な文書の一つです。あなたには、これまでの専門知識を活かして、わかりやすく、正確な添付文書を作成することで患者さんの健康に貢献することができます。

　　RA Labelingの業務としては、申請準備ではJSTに参画して製品価値が最大化される添付文書の作成を目指し、市販後は規制当局との折衝、チームやGlobalと協働しながら常に最新の製品情報を提供できるよう添付文書を維持します。また、包装表示では、規制に従ったわかりやすい包装表示を保証するとともに、国内外の製造所、品質保証部、流通など幅広いStakeholderと連携して製品の上市や市販後の安定供給に貢献します。

　　Major Accountabilities:

　　. Ensure compliance of (NPI) and artwork with all Japanese regulations.

　　. Assist facilitating harmonization and consistency between NPI and global product information documents (e.g. CDS).

　　. Communication/negotiation with Global Labeling and provide input from Japanese regulatory perspective as needed.

　　. Communication/negotiation with PMDA regarding NPI in collaboration with related line functions.

　　. Submit, finalize and print final draft of all NPIs as required in the designated timeframe on SOPs.

　　. Finalize the artworks as marketing authorization holder.

　　. Manage the artwork administrative office.

　　. Actively working with other line functions (e.g. Development, Production, Marketing, Sales) to facilitate preparation and changes of NPI.

　　. Assist establishing and maintaining procedures for preparation of Japanese labeling

　　. Maintain IT system, database as PI manager (e.g. PMDA home page, Intra, DRAGON, CCEx).

　　. Support/Coach PI Junior associates for daily work

　　. Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures

　　. 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.

　　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 [email protected] 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 [email protected]

　　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。

　　Diversity & Inclusion / EEO

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

　　Role Requirements

　　Education:

　　. Life Sciences or Pharmaceutical in University

　　. Pharmacist license is preferred

　　. Master degree is desirable

　　Experience/Professional requirement:

　　. 3 years or more experience in regulatory affairs or Safety/PV, and be counted as an expert for Japanese regulation.

　　. Train and mentor RA members concerning the requirements on prescribing information.

　　. Possess extensive knowledge of MHLW/PMDA management, structures and organizations, and maintain trustful working relationship with MHLW/PMDA and academia.

　　. Address scientific issues across line functions and implement action plans.

　　. Define internal procedures for complying with new regulatory requirements and enhancing quality and efficiency of the processes.

　　. Clarify discussion items on PI matters and raise key points to focus on in English.

　　. Possess a comprehensive overview of the global competitive environment in the industry.

　　. Ensure the commercial objectives in the target product profile.

　　. Represent RA at various cross functional meetings and provide and solicit input to/from other functions.

　　. Interpret and communicate evolving/future changes in specific requirements and environment.

　　. Maintain long-term relationship with internal/external working groups, ensure that all contributors receive accurate and timely organizational communications, and give full support and encourage team in making a challenge.

　　English Skill:

　　. English as business language.

　　Division

　　Development

　　Business Unit

　　REG AFFAIRS GDD

　　Location

　　Japan

　　Site

　　Tokyo

　　Company / Legal Entity

　　Novartis Pharma K.K.

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No