患者さんのためにあなたの力を発揮してください

JOB SUMMARY
Primary Purpose / Regulatory Responsibilities:

Responsible for tasks below as Japan Regulatory Scientist on assigned projectPrepare and implement Japan regulatory strategic and operational plans of development products and LCM in line with UCBJ/ global RA strategy with support from Regulatory Science LeadPrepare and review regulatory submission documents, PMDA briefing documents, CTN documents and response documentsEnsure quality of the regulatory documents according to UCB quality standards and manage quality regulatory submissionsProvide strategic and operational regulatory input and guidance in cross-functional teamsBuild effective relationships with regulatory agencies and external parties (PMDA/MHLW/Academia/Industry associations)Work flexibly to provide broad operational support to ensure the delivery of business objectives

 

MAJOR RESPONSIBILITIES

Accountable for tasks below as Japan Regulatory Scientist on assigned project

Prepare and implement Japan RA strategic and operational plans of development products and LCM in line with UCBJ/global RA strategy with support from Regulatory Science Lead.Lead the delivery of timely regulatory approvals as a member of Development/Submission team with Regulatory Science LeadLead the planning, preparation and delivery of regulatory submissions and PMDA consultations with support from Regulatory Science Lead.Prepare and review Regulatory submission documents, PMDA briefing documents, CTN documents and response documents with agreed timelines.Manage local e-CTD publishing processes for quality and on-time NDA submission.Ensure quality of regulatory documents in compliance with UCB quality standards.Provide regulatory expertise on regulatory submissions, applications and regulatory document preparation to global and local development/submission teams, while liaising proactively with relevant functions.Assume assigned responsibilities for routine and non-routine contact with PMDA and UCB global.Build effective relationships with regulatory agencies and external parties (PMDA/MHLW/Academia/Industry associations).Assist in development of regulatory standards and SOPsDevelop regulatory knowledge and behavior according Personal Development PlanGuide RA staffs and support Japan RegulatoryAppropriately use budgets of Japan Regulatory to meet objectives

 

EDUCATION & QUALIFICATION

Education Level: Bachelor's Degree or Master's Degree(Preferable)

COMPETENCIES

Thorough understanding of Japanese regulations and regulatory proceduresReview skills for regulatory documentsAbility to communicate and give presentations in English and JapaneseAbility to manage and communicate well with other RA staffs, other functions and CROs.Ability to build and manage effective relationships with regulatory agency.Abilities to decide what to do based on the situation, to change behavior or approach to fit the situation or the person and to work effectively in ambiguous situations (Flexibility and adaptability)Ability to lead an assigned cross-functional team in order to achieve key outcomes with agreed timelines

※フルリモート不可/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

 

患者さんのために価値を創造し、あなたの力を発揮して「その先」に進む準備はできていますか？もしそう思われるなら、ぜひご応募ください！

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。

UCBにおけるサステナビリティと、それが私たちのビジネスアプローチにどのように統合されているかについては、こちらをご覧ください。

UCBとその子会社は、職場における多様性と包括性を奨励しています。人種／肌の色／宗教／性別／国籍／退役軍人／障害／年齢／性的指向／性自認による差別は行いません。

あなたの強みや能力を発揮するために、日本での職種への応募に特別な配慮が必要な場合は、Ucb_recruit@ucb.com までご連絡ください。その他のお問い合わせの場合、このルートではサポートできませんのでご注意ください。