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Consultant, Regulatory and Access Consulting /新薬開発計画・承認申請サポートCMCのコンサルタント

Japan, Remote Date posted 01/25/2023 Job ID R0000005180

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

職務内容:

  • プロジェクトリーダーの指示のもと、新薬開発段階での開発戦略及びCMC薬事戦略策定から製造販売承認申請及び承認取得後の製品の変更管理に関わるCMC薬事業務全般。また、クライントと協議、交渉を行う。
  • パレクセルの業務遂行手順を順守する。
  • クライアントに提出する成果物に、新たに習得した知識を効果的に反映させる。

業務内容

プロジェクトにアサインされた後、クライアントと協同して、下記のコンサルテーションやCMC関連の薬事申請資料を作成サポートします。

  • 薬剤開発におけるCMC関連の既存成績並びに情報の分析並びに評価
  • 日本での臨床開発計画及び薬事申請のためのCMC薬事戦略の策定。
  • 製造販売承認申請資料(新規申請、一変申請及び軽微変更届)の作成及び申請。
  • PMDA相談資料作成及び規制当局との照会事項対応。
  • 申請後の照会事項対応及びPMDAとの対応支援を行い、製造販売承認を取得。
  • 医薬品原薬等登録原簿(MF)及び外国製造業者認定(FMA)手続きの支援
  • GMP適合性調査サポート
  • カルタヘナ法に係る申請手続きの支援
  • 医薬品原薬等登録原簿の国内管理人業務(変更管理における薬事評価を含む)
  • 様々な薬事コンサルティング

条件:

  • 技術的能力
  • 製薬会社における医薬品開発(もしくはCROでの勤務)におけるCMC薬事経験3年以上
  • 製薬会社における製剤開発又は分析研究等のCMC研究経験、または製造施設での品質管理(製造管理、分析・試験)等の経験
  • 製造販売承認申請書作成、CTD作成、医薬品原薬等登録原簿の作成などの経験
  • 生物製剤に関するCMC経験者なら、尚可
  • 最終学歴:  大学卒(薬学もしくはその他の自然科学分野の専攻)

  • インターパーソナル能力
  • コミュニケーション能力
  • ロジカルシンキング
  • 英語での業務上のコミュニケーションが可能(スピーキング、ライティング)
    • コンサルタント> TOEIC 700(目安)

#LI-REMOTE

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