Regulatory Scientistの求人情報なら転職エージェントJAC

求人情報

Regulatory Scientist

  • 転勤なし
  • 週休二日制
  • 上場
  • 外資
求人番号

NJB1042586

[無料]転職サポートのお申し込み

会社名 社名非公開 <業種:メディカル・バイオ - 製薬>
職種

メディカル・バイオ-薬事申請

雇用形態 正社員(期間の定めなし)
勤務地 東京都
仕事内容

・Plans Japan RA strategies of development products and LCM in line with UCBJ/ global RA strategies with GRA Lead and relevant people in DevMed Asia

・Implements the application dossier preparation including the CTN and CTD for the NDA and approval

・Ensures that documents submitted for publication and submission are published on the time and UCB quality standards

・Build CTD preparation process and publishing including Electric Document Management System

・Member of LLC and put into the agenda for new labelling or labelling change to GLC

・Appropriately controlling budgets of RA Japan to meet objectives

・Resolves to prevent problems related to the import, manufacture, and sales of market products

・Manages UCBJ’s Manufacturing and Marketing Authorization

・Analyzes new or updated information on regulatory area

・Develops RA knowledge and skills according the PDP


■休日:完全週休二日制

求める経験、能力
年齢制限の理由

Experience (List the type and length of experience)

・Minimum 6 years of experience within the pharmaceutical industry or official institution.

・Minimum 3 years of experience in CTD within the pharmaceutical industry.

・International collaboration preferred.

・Demonstrates ability to develop and manage internal/external business relationships.

・Hand-on experience in some phases of regulatory process, content expert in one or more areas of product development and life-cycle

Specific skills/competences (Include specific skills and knowledge necessary to meet the objectives of the role)

・Ability to manage and communicate well with other RA staffs and departments

・Ability to write & review RA documents, ability to plan regulatory strategies

・Ability to lead & manage LLC

Problem solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing and solving problems)

・Controls and works effectively within teams to achieve completion of assigned tasks within agreed timelines

・Displays attention to detail and commitment to delivering high quality outputs

・Controls and works with team member to identify and resolve key project risks and issues

・Member of LLC, put into the agenda and analyze impacts to GLC


■職種未経験者:不可

年収 600万円 - 1000万円
語学力
英語力: 
中級
 

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