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(Senior) Director, Regulatory & Access Consulting

, Japan Date posted 05/30/2025 Job ID R0000033848

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:
クライアントである製薬会社(主に海外バイオテックカンパニー)等と良好な関係を築き、さまざまな要望・期待に応え、満足していただけるサービスを提供することで、当社とクライアント双方にとってWin-Winとなるようコンサルテーションサービスを提供していく。さらにビジネスの拡大になるよう、営業担当と協力していく。
●プロジェクトごとに適切に専門性の高い人材を配置できるよう、適切なリソースプランを作成、推進する。
●プロジェクトのバジェット管理、プロジェクトプランに関与し、複数のプロジェクトのプロフィットを確保できるよう
 にする。
●売り上げに影響するイシューや問題を防止、解決につなげる。
●部下のマネジメント業務(部門目標の説明、業務の割当て、メンバーへの指導育成、能力開発、ジュニアスタッフのメ
  ンターなど)
●仕事内容と品質をレビューし、クライアントの期待やビジネスユニットの期待が満たされるようにする。
●クライアント(治験依頼者)に代わって、規制当局への対応(治験国内管理人となる為、日本の規制を知らない海外ク
  ライアントへの説明やソリューションを提供)し、依頼者の満足度をあげたり、ビジネスの獲得につなげる。

●新規プロジェクト獲得に繋がる市場調査および情報収集(新規/既存クライアント、業界ネットワーク、社内営業tチー
ムを通じて)を実施

●新規・既存クライアントとの関係維持およびリピートビジネスの推進

必須業務経験・求める人物像:

●10年以上薬事/開発部門に在籍していた方(薬事経験なくても、可)
●プロジェクト管理、ピープルマネジメントの経験者
●業務を地道にコツコツとミスなく行える人が望ましい。(辛抱強く、ストレスを上手く発散できる方、が望ましい)
●海外とのEメールや電話によるコミュニケーションと、プレゼンテーションが英語で支障なくできる方

語学

【必須】英語上級

Required Competencies

・ Influencing others
・ Client-focused approach to work
・ Networking
・ Results orientation
・ Business analysis
・ Excellent interpersonal and intercultural communication skills, both written and verbal Teamwork and collaboration
・ Critical thinking and problem-solving skills
・ Holding people accountable
・ Operational leadership
・ Leading change
・ Strategic business thinking
・ Consulting skills


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