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

■ 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

■ 応募資格（経験、資格等）/ Qualification (Experience & Skill etc.)

【経験 / Experience】

＜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 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

＜歓迎 / Nice to have＞

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

【語学 / Language】

＜必須 / Mandatory＞

日本語 Japanese : Native level

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】

E

【勤務地 / Work Location】

Osaka or Tokyo