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薬事機能リーダー / Regulatory Leader
| Hiring Company | 中外製薬株式会社 |
| Location | Tokyo - 23 Wards |
| Job Type | Permanent Full-time |
| Salary | 7 million yen ~ 12 million yen |
Job Description
【求人No NJB2057148】
仕事内容：
がん、神経、自己免疫等の各疾患領域や新規モダリティの製品開発において：
■開発～市販後における薬事戦略の立案および当局折衝（PMDA/MHLW/FDA/EMA/China/Taiwan/Korea）を行う。
■機能横断（CMC、非臨床、臨床、安全性）のメンバーで構成される申請・審査対応チームを統括し、国内申請・審査対応計画の立案・実行を行う。
■ロシュのGlobal regulatory leader及び中外の海外子会社と連携、協働する。
Description of work:
As for products development in Oncology Neuroscience Immunology and other disease areas and other novel modalities:
To provide regulatory strategies and lead negotiation with health authorities （PMDA/MHLW/FDA/EMA/China/Taiwan/Korea） through development phase to post approval phase;
To establish a filing strategy/plan and implement Japanese NDA filing towards approval by leading NDA filing team consist of related function members （CMC/non clin/Clinical/Safety）;
To work and collaborate with Roche global regulatory leader and Chugai affiliates.
【所属部署】
プロジェクトライフサイクルマネジメントユニット（PLU）
General Requirements
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Native |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
Required Skills
求める経験： ・5年以上の薬事経験 ・機能横断のチームでのプロジェクト経験 ・海外薬事対応経験（欧米またはアジア主要国の当局相談/IND/CTA等）があれば尚望ましい 求めるスキル・知識・能力： ・国内の薬事規制、ガイドライン（ICHガイドライン含）に関する知識 ・状況を多面的に分析・評価し、薬事課題・問題点を抽出、解決策やリスク対応策を立案する問題解決力 ・多様なプロジェクトメンバーと関係を構築しチームを運営する能力 ・科学的議論をベースとした交渉力 ・日本語の読解力、文章作成力、論理構築力、コミュニケーション力 求める行動特性： ・チームメンバーと協働しながら目標を達成する ・新しいことに好奇心を持って、吸収しようとする ・困難な状況に置かれても、自らモチベーションを高めて、パッションを持って業務に取り組む 必須資格（TOEICを含む）： ・TOEIC 730点以上 Desired experience: ・A minimum 5 years regulatory affairs experience ・Experience working with cross functional project team ・Experience working with global regulatory activities （e.g. IND/CTA/HA meetings in US EU and/or Asia） is highly preferred Desired skills/knowledge/abilities: ・Strong knowledge of Japanese regulations/guidelines （including ICH GL） ・Ability of Problem Solving Approach including assessing situations from multifaceted viewpoints extracting regulatory problems/challenges and proposing solutions and risk mitigation plan. ・Management capability to establihsh relationship and proceed project across multi functional members ・Ability of negotiation skill based on scientific discussion. ・Fluent in Japanese language skills including reading writing strategic thinking and communication Desired competencies: ・Achieve strategic goal emphasizing cross functional cooperation. Self learning attitude to deepen understanding and knowledge with curiosity. Self motivated attitude to work independently and passionately addressing difficulties. Desired Qualification： TOIEC score over 730 pointsJob Location
- Tokyo - 23 Wards
Work Conditions
| Job Type | Permanent Full-time |
| Salary | 7 million yen ~ 12 million yen |
| Work Hours | 08:45 ～ 17:30 |
| Holidays | 【有給休暇】初年度 18日 1か月目から 【休日】完全週休二日制 年末年始 国民祝日、フレックス休日（年間４日）、年次有給休暇… |
| Industry | Pharmaceutical |
Job Category
- Medical, Pharmaceutical and Healthcare > Patent Specialist, Academic
Company Details
| Company Type | International Company |
