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Manager, Neuroscience & Marketed Products, Regulatory Affairs/ 薬事部 ニューロサイエンス&マーケットプロダクトグループ 課長代理

Apply Now Email Me Job ID R0011594 Date posted 09/04/2019 Location: Osaka, Japan

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Job Description

Please note that this job requires native level Japanese language command not only in speaking, but also in business writing and reading.

タケダの紹介

タケダでは、常に患者さんを中心に考え、その生活を豊かにするためにイノベーションを推進しています。そして、従業員一人ひとりにそれぞれの能力と熱意に応じた成長の機会を提供することにも組んで取り組んでいます。私たちと一緒に、世界中の人々のいのちに貢献し、さらなる成長と活躍を目指しませんか。

タケダは約3万人の従業員が、世界中の国や地域で働くグローバルな企業です。すべての従業員が世界中の人々の生活をより良いものにしたいという信念をもち、そしてタケダイズム(誠実:公正・正直・不屈)を日々の業務で体現しています。私たちは、237年の研究開発型の製薬企業としての伝統のもと団結し、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ことをミッションとして掲げています。

Takeda is unwavering in our commitment to patients. With the patient at the center of everything we do, we continue to innovate and drive changes that will better their lives - we’re looking for like-minded professionals to join us.

Today, we are the number one pharmaceutical company in Japan and a global industry leader, with approximately 30,000 employees around the world. We are united by our four priorities (patient, trust, reputation and business) and Takeda-ism (Integrity, Fairness, Honesty and Perseverance) , and strive towards better health and a brighter future for people worldwide.

募集部門の紹介

日本開発センター 薬事部 ニューロサイエンス&マーケットプロダクトグループ/Japan Development Center, Regulatory Affairs Department, Neuroscience & Marketed Products

ニューロサイエンスTAU品目、MPG品目及び他のTAUに属さない市販製品について、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。

  • Collaborates to define, develop and lead Japan regional strategies to maximize regulatory and patient access success to enable patient access to meaningful medicines in alignment with program objectives. 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 oversight of marketed product support, while maintaining full compliance with applicable regulatory requirements.
  • Provide regulatory expertise for multiple projects and/or one highly complex project for assigned development project and / or marketed product(s) of responsibility.
  • Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning to future business requirements.
  • Primary Japanese regulatory authorities contact for project(s)/products of responsibility or can delegate to vendor with oversight. Informs the business. Manages interactions with Japanese regulatory authorities for specific product(s).

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.
  • Where responsibility includes a marketed product, provides oversight to ensure regulatory compliance, including oversight of the product related data in the registration database. 
  • Accountable for working with other RA functions 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 and /or marketed 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 TA 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.

  • Product Information (NS&MP G only)

Gather and Provide regulatory information for the existing products in response to queries from internal or external customers.

  • Ad/Promo

Support Regulatory Review for promotional materials and publications

応募要件

<学歴>

  • MSc preferred

<実務経験>

  • Basic knowledge of regulations and medical in the assigned TA.
  • People management experiences is not mandatory
  • Overseas work experience is not mandatory

<スキル・資格>

  • N/A

<語学>

  • Fluent English language skill is desired in oral and written commutation
    (e.g. TOEIC: 730 points).

待遇

諸手当:通勤交通費、借家補助費、勤務時間外手当など

昇給:原則年1回 

賞与: 原則年2回

勤務時間:本社(大阪市中央区・東京都中央区)9:00~17:30 、工場(山口県光市・大阪市淀川区)8:00~16:45 、研究所(神奈川県藤沢市)9:00~17:45

休日:土曜、日曜、祝日、メーデー、年末年始など(年間123日程度)

働き方関連制度:フレックスタイム制、テレワーク勤務制導入(対象社員)

休暇:年次有給休暇、特別有給休暇、リフレッシュ休暇、産前産後休暇、育児休暇、

子の看護休暇、介護休暇、フィランソロピー休職制度

タケダのダイバーシティ&インクルージョン

Empowering Our People to Shine

Locations

Osaka, Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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