外資系製薬メーカー　Japan Regulatory Lead, BioPharma Therapy Area

資格・要件

＜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)

職務内容

• 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

【その他情報】
契約期間：期間の定めなし
試用期間：6か月
就業時間：9:00～17:15
休憩時間：60分
フレキシブルタイム：あり
時間外労働：あり
休日休暇：
完全週休2日制（休日は土日祝日）
年間有給休暇　初年度12日
年間休日日数121日