Regulatory Affairs

6日前

Minato 711 GlaxoSmithKline K.K. Full time

職務の目的

開発品目の承認申請時の添付文書案作成等:

  • 薬事規制及びGSKポリシーに従い、申請内容に基づく添付文書案作成においてプロジェクトチームをリードする。
  • CCDSに基づく添付文書の記載事項が承認されるよう、承認審査における添付文書関連照会事項に対する回答作成をリードする。

    • 市販品目の添付文書管理:

  • 薬事規制及びGSKポリシーに従い、最新の情報に基づく添付文書の改訂及び改訂添付文書の公開を滞りなく行う。
  • 添付文書に係るカスタマーからの問い合わせに対して適切に回答する。

    • アートワーク管理:

  • 必要な薬事Inputを行い、アートワークの変更及び製品への封入切り替えが滞りなく行われるように取り計らう。

    • 市販後薬事:

  • 市販品目のライフサイクルマネジメント(主にCMCの変更管理)に関連し、規制当局及び社内関連部署と良好な関係を築き、規制当局との窓口業務を適切に遂行する。

    • 主な業務内容

  • 承認申請資料(添付文書案含む)の作成・改訂
  • 承認申請時の添付文書案作成における取りまとめ
  • 承認審査時の添付文書関連照会事項に対する回答作成
  • 添付文書改訂相談における当局窓口
  • 添付文書改訂版の校正
  • 添付文書の届出
  • PMDA 公開サイトの企業ページ管理・必要情報の登録・公開
  • 添付文書に係る外部問合せに対する回答
  • 患者向医薬品ガイドの作成・改訂、当局への改訂相談、公開
  • 市販品目の変更管理に関する薬事業務
  • 業許可管理の業務
  • 当局対応での、承認時期への影響や承認後のグローバルビジネス及び国内での市販製品の供給への影響等を鑑みた方針決定
  • 業界団体・学術団体等を通じた薬制に関する規制調和の推進
  • ライフサイクルマネジメントに関連する市販後薬事の業務全般におけるタイムライン管理、薬事的課題の把握及び解決策の提案、当局交渉等のマネジメント

    • 必要な条件

  • 医薬品開発、薬事関連業務、変更管理業務あるいは安全性管理業務の経験
  • 海外とメール又は口頭でコミュニケーションができる英語力
  • 当局関係者と交渉するためのコミュニケーション能力
  • 基本的なITスキル(Word, Excel, Power Point等)
  • 向上心があり、変革に対して前向きであること

    • 望ましい条件

  • 薬剤師

    • Why GSK?

    Uniting science, technology and talent to get ahead of disease together.

    GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

    Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

    Important notice to Employment businesses/ Agencies

    GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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