【AstraZeneca】【R&D】Japan Regulatory Lead, Oncology Therapy Area, Japan TA Regulatory Strategy & Policy Department, Regulatory Affairs Division

＜本ポジションの魅力＞
オンコロジー領域の開発薬事メンバーとして、本ポジションでは社内外のステークホルダーとの円滑なコミュニケーションスキル、豊富なパイプラインのもと、アンメットニーズがある様々な癌腫における薬事戦略の構築および承認申請の経験を積むことができます。キャリアパスとしてはプロジェクトリーダー、senior JRL、Global組織における薬事担当者など社内公募制度を利用し、一人一人のキャリアプランに応じた様々なキャリアパスが想定されます。
開発戦略における薬事戦略の構築および承認申請の中心的メンバーとして、一緒にがん患者さんの人生を変える薬を開発しませんか？リーダーシップを発揮し、チームワークにやりがいを感じる候補者からのご応募をお待ちしております。
■ 職務内容 / Job Description

• Japan Regulatory Lead (JRL) is responsible for planning and execution of Japan regulatory strategy of the assigned products/projects by
  

▻Providing strategic regulatory expertise for optimum market access of the products in Japan as a member of Japan project team and Global Regulatory Strategy Team (GRST)
▻Leading communication of the global regulatory strategy and its implication to Japan so that the context of regulatory input are properly understood by the governance bodies in Oncology R&D (ORD) and BioPharma R&D (BRD) for their quality decisions through communication with GRST/Global regulatory execution team (GRET).
▻Preparing, updating, and implementing regulatory operational plans to deliver regulatory outcomes of the assigned products/projects.
▻Managing quality regulatory deliverables of the assigned products/projects throughout the product’s lifecycle.

• JRL works flexibly within and across the Therapeutic Areas to provide broad operational and/or strategic support to ensure regulatory deliverables
  

【経験 / Experience】
■ 応募資格（経験、資格等）/ Qualification (Experience & Skill etc.)
＜必須 / Mandatory＞

• Relevant regulatory experience or experience elsewhere in Pharmaceutical industry
• Cross-functional project team experience
  

＜歓迎 / Nice to have＞

• Experience in regulatory drug/device development in oncology area, approval and launch
• Successful contribution to a major regulatory approval at a regional level
• Proven leadership and program management experience
  

【資格 / License】
＜必須 / Mandatory＞
Bachelor’s Degree in Science or related discipline
【能力 / Skill-set】
＜必須 / Mandatory＞

• Team working
• Thorough knowledge of the drug development process
• Written and verbal communication skills
• Scientific knowledge sufficient to understand all aspects of regulatory issues
  

＜歓迎 / Nice to have＞

• Ability to think strategically and critically evaluate risks to regulatory activities.
  

【語学 / Language】
＜必須 / Mandatory＞
英語 English：Business English (Writing and verbal communication)
＜歓迎 / Nice to have＞
Business English (Achieve common understanding at the context level with customers)
【キャリアレベル / Career Level】
D or E
【勤務地 / Work Location】
Osaka or Tokyo
職種の紹介と働く社員の魅力をビデオにて紹介しております（https://www.astrazeneca.co.jp/recruit.html）
ご応募についてのご質問、中途採用についてのフィードバックなどございましたらJapan.Recruit@astrazeneca.comまでご連絡お待ちしております。