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企業名 武田薬品工業株式会社

東京/製薬開発薬事

案件No.H27819

事業内容
■事業内容
医薬品等の研究開発・製造・販売・輸出入

■優れた医薬品の創出を通じて人々の健康と医療の未来に貢献する
タケダは、世界中のあらゆる人々のニーズに貢献しています。
タケダイズムを通じ、社会やタケダの医薬品を必要とする方々からの信頼を得ています。
タケダイズム(誠実:公正・正直・不屈)とPatient:患者さん中心、Trust:社会との信頼関係構築、Reputation:レピュテーションの向上、Business:事業の発展、の順に重視する考え方は、常に高い水準を追求する、正しい行動に取り組む、という私たちの働き方に深く根付いています。

■グローバル企業として
タケダでは世界の70を超える国と地域で、約30,000人の従業員が、世界中の人々の健やかで明るい未来に貢献しています。
また、新興国と先進国の市場特性に合わせ、競争力の高い製品を構築。
世界約80ヶ国に事業基盤を有するグルーバル製薬企業として更なる発展を目指しています。
仕事内容
オンコロジー品目について、患者にとって価値を最大化する開発、承認申請、承認維持、添付文書構築にかかわる行政折衝戦略を立案・実行する部門です。

– Defines, develops and leads Japan regional strategies to maximize regulatory and patient access to enable patient access to meaningful medicines in alignment with program objectives. (Small-modules, Anti-body, and Regenerative medicine)
– Effectively communicates objective assessments of the likelihood of success of these regulatory strategies. Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs and/or CDx, while maintaining full compliance with applicable regulatory requirements.
– Provides regulatory expertise for multiple projects or for one highly complex project (e.g. global project with multiple indications and presentations), focused on non-clinical and clinical aspects of drug development and/or post-marketing compliance and life cycle management.
– Provides leadership and development for multiple direct reports and/or team members for the design and execution of regional and / or Japan regulatory strategies in collaboration with their global counterparts, and value and access teams.
– Act as deputy to RA Director, attending internal or external leadership team meetings, as appropriate.
– Provides direction to leadership and teams on emerging trends, regulations and changes, with emphasis on those related to therapeutic areas and/or region of responsibility enabling proactive approach and planning to future business requirements.
– Manages and oversees interactions with Japanese regulatory authorities in defined therapy area scope(Provides interpretation to the business).

【職務内容】
– Leads the regulatory working team for Japan and represents as needed at project team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan – or oversees if delegated and/or vendor.
– Partner with the Japan market access and to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into Japan product development plans.
– For the project(s)/product(s) of responsibility, collaborates with Global and Regional colleagues for the authoring of global regulatory strategies and ensures own critical deliverables as agreed within the global regulatory strategy and planning.
– Accountable for working with other RA functions(CMC, Operations) and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within Japanese responsibility.
– Identifies relevant Japanese regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned project(s) of responsibility. Authors and reviews Japan regulatory strategies as well as executes day-to-day activities for projects or may delegates to vendor with oversight.
– Usually includes supervision of vendor activities.
– Leads and manages meetings and/or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and/or vendor; negotiates on behalf of project team as necessary.
– Regulatory reviewer in due diligence for licensing opportunities, development product opportunities.
– Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc.) contacts/influence to achieve Takeda strategic goals and objectives.
– Identifies regulatory requirements and trends across area(s) of responsibility, and provides regulatory guidance, and expertise to Japan development team and/or higher governance bodies in these areas, as requested.
– Identifies and proposes solutions to the management of resource gaps for areas of responsibility.
– Presents to senior management as requested.
– Labeling management for oncology products.
Develop labeling strategy and draft labeling for NDA/PCA submissions considering characteristics of the disease/compounds, trends in the industry, pricing/reimbursement system, PTRB etc.
Maintain JPI including revisions and its management, necessary regulatory procedures and coordination of relevant functions. etc.
– Ad/Promo
Support Regulatory Review for promotional materials and publications
応募資格 ≪必須≫
【実務経験】
・新薬の開発薬事の経験者(5年以上)
・開発フェーズが早期~後期の品目に対する戦略立案ができる方

【語学】
・海外の薬事部門とのビジネスコミュニケーションが出来る英語力(TOEIC730点相当以上)。
 且つ、ビジネスレベルの日本語力

勤務地 ≪東京グローバル本社≫東京都中央区日本橋本町2丁目1-1
★JR総武線「新日本橋駅」徒歩1分
★東京メトロ銀座線「三越前駅」徒歩2分
勤務時間 ■フレックスタイム制
標準的な勤務時間9:00~17:30
・所定労働時間7時間45分 ・休憩:45分
・残業:有
想定年収 ■想定年収600万円~1,200万円※前職の給与を考慮して決定いたします。
・月給35万円~75万円
・昇給:原則年1回
・賞与: 原則年2回
休日・休暇 ■年間休日123日※土日祝日休み
・完全週休二日制(土日)
・祝日
・メーデー
・年末年始休暇
・年次有給休暇・特別有給休暇・特別有給休暇(慶弔、災害等)
・短期・長期傷病休暇
・リフレッシュ休暇
・ファミリーサポート休暇、産前産後休暇、育児休暇、介護休暇、子の看護休暇、短期介護休暇
待遇・福利厚生 ・社会保険完備
・交通費支給※規定あり
・借家補助費※規定あり
・在宅勤務制度
・禁煙オフィス
受動喫煙防止について 屋内全面禁煙
雇用形態 正社員

試用期間3ヶ月
雇用期間の定め
選考プロセス 書類選考→面接2~3回、筆記試験あり→内定
企業情報 会社設立日
1925年1月

従業員数
5,291名(単体)49,578名(グループ全体)※2019年3月末時点

資本金
1兆6,435億円

売上高
6,513億円(単体)

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