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【R&D】Japan Regulatory Lead (JRL), Regulatory

Ort Ōsaka, Ōsaka-fu, Japan Kita-ku, Tokyo Prefecture, Japan Anzeigen-ID R-094737 Veröffentlichungsdatum 06/02/2021

■ 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
  • 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(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-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 English (Speaking level 6 or above)

【キャリアレベル / Career Level】

D or E level

【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.

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