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

求人情報

Sr Associate Regulatory Labeling

  • 転勤なし
  • 週休二日制
  • 上場
  • 外資
求人番号

NJB1025788

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会社名 外資製薬メーカー <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

メディカル・バイオ-安全性情報(臨床開発/製販後GVP)

雇用形態 正社員(期間の定めなし)
勤務地 東京都
仕事内容

<Group Purpose>

Facilitate patient access to our products in Japan through executing the development and regulatory plans; providing strategic regulatory expertise; interfacing with agencies on regulators; aligning with key cross-functional partners; integrating into Amgen’s commercialization process, and continuously improving our processes and developing our talent

<Job Summary>

Develop and maintain local labels and package inserts with Global Labeling Working Team, local Development Regulatory Team, Reg CMC, Global Patient Safety Team, Operations, and Marketing Team

Provide local regulations and regulatory guidance for labeling and package inserts to responsible functions including global functions

Ensure quality of regulatory documents such as labels and package inserts by executing compliance check

<Key Activities>

・Closely communicate with responsible functions (Global Labeling Working Team, local Development Regulatory, Regulatory CMC, Global Patient Safety, Operation, Quality, and Commercial & Marketing) to update and manage labels and package insert in a timely manner

・Provide and educate local regulations and requirements for labeling and package inserts to responsible functions (see above)

・Execute QC for regulatory documents such as labels to be uploaded to PMDA’s web-site, package insert, J-NDA application form, and other key essential regulatory documents.


■休日:完全週休二日制

求める経験、能力
年齢制限の理由

<Knowledge and Skills>

・J-NDA filing and registration skills of medicines in Japan

・Knowledge for local regulations and requirements for labeling and package insert

・Negotiation skill for label and package insert with Japanese Health Authorities

・Negotiation skill for label and package insert with Global Labeling Working Team

・Working in matrix environments in Japan and global teams as the One Team

・Communication skills

・English and Japanese conversation, read, and writing

・IT skills: Microsoft Outlook/ Word/ Excel/ Power Point

<Education & Experience>

・Bachelor degree and at least 10 years of pharmaceutical industry experiences including at least 5 years in regulatory affairs or approval of at least 2 products from NDA filing to approval

OR

Master’s degree and 8 years of pharmaceutical industry experiences including at least 5 years in regulatory affairs or approval of at least 2 products from NDA filing to approval

<Education & Experience (Preferred)>

・Knowledge for labeling and package insert preparations, approvals, and maintenance in Japan (more preferred biologics and/or combination product experiences)

・Negotiation for content of label and package insert with PMDA


■職種未経験者:不可

年収 700万円 - 900万円
語学力
英語力: 
中級

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