Description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
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.
Responsibilities
- 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
Requirements
- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- 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.
- Willingness to travel as required (approximately 5%)
- 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
Rewards & Benefits
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways