Senior Manager, Regulatory Affairs

Senior Regulatory Scientist-Tokyo Osaka- Office Hybrid/Home

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Job Advert Posting

We are currently seeking a Senior Regulatory Scientist to join our diverse and dynamic team. As a Senior Regulatory Scientist at ICON, you will provide advanced regulatory and scientific expertise to support global clinical development strategies, submissions, and health authority interactions. You will help navigate complex regulatory landscapes to enable successful programme execution.

What You Will Be Doing:

• Leading or significantly contributing to regulatory strategy development for clinical programmes and key milestones.

• Authoring and reviewing complex regulatory documents, including clinical trial applications, briefing documents, and major submission components.

• Interpreting global regulations, guidelines, and precedents and advising cross-functional teams on regulatory expectations and risk.

• Participating in or leading interactions with health authorities, including meeting preparation, presentation support, and follow-up.

• Providing regulatory input into clinical development plans, risk management strategies, and labelling considerations.

• Mentoring junior regulatory staff and contributing to internal standards, templates, and best practices.

• 薬事関連資料（各種面談資料、治験届等）の作成

• 当局との連携・新薬申請から承認取得までの各種対応・進捗管理

• 社内他部門との連携と薬事観点のアドバイス提供

• 薬事戦略の提案やプレゼンテーション

• 新規事業獲得にむけてクライアントへのアプローチ

• CMC関連文書作成・CMCコンサルティング全般

• 業務関連通知・規制アップデートの全体共有　　　　　　　等

• ※業務プロジェクトについてはManagerと複数名のチームを組んで対応をいただくことを想定しています。

Your Profile:

• Advanced degree in life sciences, pharmacy, medicine, or a related discipline, or equivalent regulatory experience.

• Substantial experience in regulatory affairs or regulatory science within pharma, biotech, or CRO.

• Strong understanding of global clinical development regulations and guidance (e.g., FDA, EMA, ICH).

• Excellent scientific writing, analytical, and critical-thinking skills, with meticulous attention to detail.

• Proven experience supporting or leading health authority interactions and complex submissions.

• Strong communication and collaboration skills, with the ability to work effectively in cross-functional teams.

• 下記の業務のいずれかを3年以上経験していること

• 規制当局との折衝やコミュニケーション、円滑なやり取りなどの実務経験

• 英語でのコミュニケーションスキル、文書作成能力

• 言語

  ビジネスレベルの英語力　

  ※海外クライアント・グローバルチームとのオンライン会議に参加し、英語での共有事項の理解、日本の状況報告および質疑応答が可能な英語レベルを求める

  その他

  Microsoft word/ Excel / PPTを業務で使用できること

  Copilotを使用した文献調査の経験があれば尚良し

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply