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Japan Regulatory Lead (JRL), Regulatory

年収:800万 ~ 1100万

ヘッドハンター案件

部署・役職名 Japan Regulatory Lead (JRL), Regulatory
職種
業種
勤務地
仕事内容 - 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 GMeds, iMeds and MedI 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 will also contributeto regulatory policy shaping within the TA by working closely with TA RAD and Regulatory Policy and Intelligence Department
- JRL will work flexibly within and across the Therapeutic Areas to provide broad operational and/or strategic support to ensure regulatory deliverables
応募資格

【必須(MUST)】

【経験 / Experience】
<必須 / Mandatory>
Relevant regulatory experience or experience elsewhere in Pharmaceutical industry
Cross-functionalproject team experience
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>
Getting drug/deviceapprovalsand supporting launch activities, such as a price negotiation, as a leading person
Drug development and regulatory affairs experience in outside of Japan
Working with external bodies, such as co-development companies and key opinion leaders, as a leading person.
Line management

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

【能力 / Skill-set】
<必須 / Mandatory>
Project management skill
Customer focused
Communication and assertiveness
Understanding of the importance of Continuous Improvement
Knowledge Sharing
Team working
Ethics –overriding commitment to integrity and high standards in self

【語学 / Language】
<必須 / Mandatory>
英語 English:Business level English

更新日 2020/06/19
求人番号 1408147

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