Senior Manager, RA CMC

2ヶ月前

Minato Novartis
Summary

Odgovoren za regulativne dejavnosti, posebej povezane s kemijo, proizvodnjo in nadzorom (CMC). Dejavnosti, kot sta priprava in objava dokumentacije REG CMC za predložitev zdravstvenim organom. Poleg tega interakcija s ha-jev na REG CMC vprašanja za podporo novih proizvodov ali post trženih izstrelitev.

About The Role

Major Accountabilities

~ Razvoj, podpiranje in prenos celovite regulativne strategije CMC, ki spodbuja strokovno znanje celovitih predpisov, da se osredotoči na inovacije in poveča učinkovitost poslovanja, hkrati pa uravnotežijo regulativna tveganja in skladnost.

~ Upravljajte in podpirajo vse globalne dejavnosti skladiščenja MCC (načrtovanje, ustvarjanje, vrednotenje, usklajevanje, skladiščenje) za izvajanje celovite strategije ponujanja.

~ Glede na urnik projekta je odobren izvirni dokument predviden za zagotavljanje dokumentacije, kakovosti in/ali časa za globalne spore in pogajanje.

~ Z oddelkom za zdravje se posvetujemo, da bi zbrali visokokakovostne dokumente CMC ter opredelili in izvajali globalne regulativne strategije MCC, trenutne trende in regulativne politike.

~ Med drugimi udeleženci projektne skupine dejavno spodbujajo ključne strategije, tveganja, izzive in življenjske kroge prek splošnih odborov in več odborov na terenu.

~ Vodnik, pisanje in poročanje o izkušnjah, pridobljenih iz ocene tveganja MCC, načrtov za obvladovanje tveganja, prispevkov ali pomembnih poročil.

~ Dialogi in sestanki ter načrti, specifični cilji, novi, dokazani in načrtovani ter Blažilni načrti.

~ Z našim strokovnim delom nudimo strateško svetovanje in svetovanje oddelku ter zagotovimo dosledno delovanje.

~ Delite svoje znanje o neizkušenih članov CMC ra in pravila.

~ Poročanje o tehničnih pritožbah / neželenih dogodkih / scenarijih posebnih primerov, povezanih z Novartis izdelki v roku 24 ur po prejemu

~ Distribucija vzorcev trženja (kjer je primerno)

Key Performance Indicators

Odgovoren za regulativne dejavnosti, posebej povezane s kemijo, proizvodnjo in nadzorom (CMC). Dejavnosti, kot sta priprava in objava dokumentacije REG CMC za predložitev zdravstvenim organom. Poleg tega interakcija s ha-jev na REG CMC vprašanja za podporo novih proizvodov ali post trženih izstrelitev.

Work Experience

~Vodenje operacij in izvrševanje

~Vodenje projektov

~Sodelovanje prek meja

~Funkcionalna širina

~Medkulturne izkušnje

~Obvladovanje kriznih situacij

~Pomembna pogajanja

Skills

~Spremeni nadzor

~Razvoj zdravil

~Vede o življenju

~Pogajalske spretnosti

~Farmacevtski izdelki

~Upravljanje življenjskega cikla izdelka (Plm)

~Skladnost s predpisi

~Upravljanje s tveganji

~Vodenje projektov

Language

Angleščina

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:
Show more Show less

  • Senior Manager, RA CMC

    2ヶ月前

    Minato Novartis ￥15,000,000 - ￥25,000,000 per year

    Verantwortlich für regulatorische Aktivitäten insbesondere in den Bereichen Chemie, Herstellung und Kontrolle (CMC). Aktivitäten wie die Vorbereitung und Veröffentlichung von REG CMC-Dokumentationen für einreichungen bei Gesundheitsbehörden. · Änderungssteuerung · Entwicklung von ...

  • Senior Manager, RA CMC

    2ヶ月前

    Minato Novartis ￥10,000,000 - ￥20,000,000 per year

    Responsable des activités réglementaires spécifiquement liées à la chimie, à la fabrication et au contrôle (CMC). Des activités telles que la préparation et la publication de la documentation reg CMC pour soumission aux autorités sanitaires. · Formuler, diriger et piloter une str ...

  • Senior Manager, RA CMC

    2ヶ月前

    Minato Novartis ￥8,000,000 - ￥15,000,000 per year

    Responsable de las actividades regulatorias específicamente relacionadas con la química, la fabricación y el control (CMC). Actividades como la preparación y publicación de la documentación de REG CMC para su presentación a las Autoridades Sanitarias. · Guía, redacción e informes ...

  • Senior Manager/Manager RA CMC, RA CMC

    2ヶ月前

    Tokyo Genmab Full time￥6,000,000 - ￥12,000,000 per year

    Genmab is a global biotechnology company that aims to improve patients' lives through innovative antibody medicines. We are a passionate and innovative team that has developed a next-generation antibody technology platform over 25 years, using translational science, quantitative ...

  • Senior Manager/Manager RA CMC, RA CMC

    1日前

    Tokyo - Midtown Tower Genmab ￥5,000,000 - ￥10,000,000 per year

    Genmab is a biotechnology company that aims to improve the lives of patients through innovative antibody drugs. · ...

  • Senior Manager, RA CMC

    2ヶ月前

    Minato Novartis ￥15,000,000 - ￥20,000,000 per year

    Odgovoren za regulativne dejavnosti, posebej povezane s kemijo, proizvodnjo in nadzorom (CMC). Dejavnosti, kot sta priprava in objava dokumentacije REG CMC za predložitev zdravstvenim organom. Poleg tega interakcija s ha-jev na REG CMC vprašanja za podporo novih proizvodov ali po ...

  • Senior Manager, RA CMC

    2ヶ月前

    Minato Novartis ￥10,000,000 - ￥20,000,000 per year

    Responsabile delle attività normative specificamente legate alla chimica, alla produzione e al controllo (CMC).Sviluppa, supporta e invia una strategia normativa CMC globale che utilizza competenze normative integrate per concentrarsi sull'innovazione per massimizzare l'efficienz ...

  • Senior Manager, RA CMC

    2ヶ月前

    Minato Novartis ￥10,000,000 - ￥20,000,000 per year

    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 evalua ...

  • Senior Manager, RA CMC

    2ヶ月前

    Minato Novartis ￥15,000,000 - ￥25,000,000 per year

    Verantwoordelijk voor regelgevende activiteiten specifiek met betrekking tot chemie, productie en controle (CMC). · Operationeel management en uitvoering · Projectmanagement · Grensoverschrijdende samenwerking · Functionele diepgang · Interculturele ervaring · Crisismanagement · ...

  • Senior Manager/Manager RA CMC, RA CMC

    2日前

    Tokyo, Tokyo Genmab

    Job summary · Genmab aims to improve patients' lives by developing innovative antibody drugs. · ResponsibilitiesMake a strategic J-NDA plan for RA CMC and execute. · Evaluate global CTD and conduct gap analysis. · ...

  • Senior Manager, RA CMC

    2ヶ月前

    Minato Novartis ￥5,000,000 - ￥10,000,000 per year

    Senior Manager, RA CMC is responsible for leading and driving global CMC regulatory strategy, ensuring compliance with regulatory requirements while maximizing business efficiency. The role involves preparing and publishing REG CMC files, interacting with HA to support new produc ...

  • CMC RA Manager

    4週間前

    Minato AbbVie ￥2,500,000 - ￥5,000,000 per year

    Deliver qualified drugs timely to patients by contributing to regulatory approval of new drugs as CMC responsibility person. · ...

  • CMC-RA manager

    1ヶ月前

    Tokyo Servier ￥120,000 - ￥180,000 per year

    The CMC RA Manager will lead and manage CMC regulatory activities, develop and implement CMC registration strategies, and support the development of the CMCRA team. The ideal candidate will have +10 years of practical experience with CMC-related roles, experience drafting and com ...

  • CMC-RA manager

    1ヶ月前

    Tokyo SERVIER MONDE Full time￥900,000 - ￥1,200,000 per year

    Lead and manage CMC regulatory activities including relevant cross-functional communication, providing guidance across the product lifecycle, and ensuring timely regulatory compliance with official guidelines. Develop and implement CMC registration strategies related to CTNs, NDA ...

  • Senior Manager, RA CMC

    2ヶ月前

    Minato Novartis ￥10,000,000 - ￥15,000,000 per year

    Özellikle kimya, üretim ve kontrol (CMC) ile ilgili düzenleyici faaliyetlerden sorumludur. Sağlık Otoritelerine gönderimler için REG CMC belgelerinin hazırlanması ve yayınlanması gibi faaliyetler. Ayrıca, yeni ürünü veya pazarlanan lansmanları desteklemek için REG CMC sorularında ...

  • CMC-RA manager

    1ヶ月前

    Tokyo Servier ￥15,000,000 - ￥25,000,000 per year

    Lead and manage CMC regulatory activities including relevant cross-functional communication, providing guidance across the product lifecycle, and ensuring timely regulatory compliance with official guidelines. Develop and implement CMC registration strategies related to CTNs, NDA ...

  • RA Manager

    3週間前

    Tokyo Barrington James ￥5,000,000 - ￥10,000,000 per year

    RAマネージャーです。グローバル企業で感染症や体外診断領域に従事することができます。コロナやインフルエンザの検査キットでマーケットシェアが2位です。 · ...

  • RA Manager

    2日前

    Tokyo Barrington James

    · 新薬・後発品(ジェネリック)の導入・維持管理を薬事の立場から担当 · 日本を含むグローバルのプロジェクトチームと連携し、薬事戦略の立案・進行管理を行う · ...

  • RA Associate Manager

    4週間前

    Shinjuku-ku, Tokyo Barrington James ￥5,000,000 - ￥8,000,000 per year

    +校らGeneral · +３４ · ...

  • RA Associate Manager

    4週間前

    Shinjuku Barrington James ￥50,000 - ￥70,000 per year

    RA Associate Manager · ２０１３: · １ · ％.４ · ...

  • Senior Manager, PR

    2日前

    Tokyo Specialized Group

    · 私注 · PR、い · ！ · ...