Senior Regulatory Scientist

🔥 2 minutes ago

🇯🇵 Japan – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Lead or significantly contribute to regulatory strategy development for clinical programmes and key milestones • Author and review complex regulatory documents, including clinical trial applications, briefing documents, and major submission components • Interpret global regulations, guidelines, and precedents and advise cross-functional teams on regulatory expectations and risk • Participate in or lead health authority interactions, including meeting preparation, presentation support, and follow-up • Provide regulatory input into clinical development plans, risk management strategies, and labelling considerations • Mentor junior regulatory staff and contribute 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 • Managerと複数名のチームを組んで業務プロジェクトに対応

🎯 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, including FDA, EMA, and 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% • 3年以上の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 • 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

🏖️ 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