Japanese Labelling & Artwork Manager

Hybrid work model

Please check if the candidate has applied for a job at UCB in the past year.　一年以内のご応募歴を必ずご確認ください。

Please make English and Japanese resume combined in one document to submit　英語と日本語の書類を一つに纏めてご提出ください。

If you have any questions, please contact recruiting team 質問がございましたら採用チームまでお問い合わせください

Primary Purpose :

Provides Japanese Labelling & Artwork Regulatory expertise across a Therapeutic business unit. Delivers strategic and operational regulatory input and guidance to the cross functional teams.

MAJOR RESPONSIBILITIES

• Creation, update and maintenance of the Japanese package inserts in line with the CCDS, Agency RTQ, and most up-to-date labelling requirements and labelling template required in Japan and according to SOPs
• If applicable, for assigned Early development assets, deliver competitive labelling searches and contributes to the TCLP for Japan (collaborating with Global Labeling Lead : GLL)
• Key point of contact for the Japanease Package Insert (digital package insert, Module 1.8) for internal (GRA + strategic Partners in Japan) and external stakeholders (clinical, medical, legal, commercial, safety, quality and be the Japan labeling representative in team meetings (DTJ, Global RST, LET, Japan Submission Team, …). Lead Reviews, Round Tables, Approvals for the Japan Labeling in the appropriate system and according to SOP
• Delivers operational excellence for all labelling activities according to timelines, such as appropriate tracking of the Japan labeling in the appropriate system and according to SOP
• Linguistic review process for ensure labelling compliance : Lead with local regulatory lead the Linguistic review according to Green book, assist with the preparation of the Closing Sequence and ensure communication of HA approved label to internal and external stakeholders according to SOP
• Lead the Local Labelling Committee (including but not limited to medical, legal, commercial, safety) for the creation, review and approval for the Japan Labeling in the appropriate ECMS and according to SOP. This may also include discussion with relevant cross-functional SMEs and Japanese Health Authorities
• Key point of contact for the Japan Artwork for GRA and external stakeholders (medical, legal, commercial, safety, quality.
• As Japan labelling & artwork expert for assigned Therapeutic Business Unit,
• the individual will build strong relationships with :

o Japan and Global Regulatory teams

o Local business partners (commercial, access, medical affairs, legal and understand their business needs

o Key partner with SPA for labelling and artwork changes

Education Level : Bachelor's Degree

COMPETENCIES

o Build effective partnerships – identifies opportunities and takes actions to build effective relationships with internal and external stakeholders, gains trust and external networking,Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions. negotiation and influencing skills to develop regulatory strategies contributing to patient value creation

o Flexibility and adaptability - Decides what to do based on the situation. Changes behaviour or approach to fit the situation or the person. Works effectively in ambiguous situations

o Communication skills – knows when and how to communicate, using strong interpersonal skills and written communications when appropriate

o Results focused – ability to overcome obstacles and achieve key outcomes

o Analytical – logically breaking situations or issues down into their essential elements : carrying out diagnosis and developing solutions

o Organizational Skills

o Integrity – Commitment to integrity and high standards in self and othersRisk management : Anticipates, identifies characterizes and escalates risks associated with our products, processes and submissions. Identifies and defines research questions and strategy, relevant data sources, methodologies and systems for benefit, safety and Risk Minimization Measures (RMM) effectiveness analysis in a rapidly evolving environment

o Leadership : Lead transversally beyond organizational borders, empower, hold accountable, drive innovation and engage around vision

UCBについて

UCBは神経学と免疫学に特化したグローバルなバイオ医薬品企業です。UCBは、世界各地に約8,500人の従業員を擁し、患者さんに触発され、科学を原動力としています。

UCBで働く理由

UCBでは、単に仕事をこなすだけでなく、価値を創造します。私たちは、患者さんのために前進し、協力し、革新することを恐れません。UCBには、思いやりがあり、協力的な社風があります。そこでは、誰もが仲間とともに尊重され、ベストを尽くす機会を公平に与えられています。私たちは、患者さん、従業員、地球のいずれに対しても、常に人間的な視点に立ち、患者さんのために価値を創造する「その先」を目指します。UCBで働けば、自分が成長できる場所を発見し、自分の可能性を最大限に発揮するために自分のキャリアパスを切り開く自由を得ることができます。

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