【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
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
