{"id":3050908,"url":"https://alion.io/job/icon-senior-regulatory-scientist","title":"Senior Regulatory Scientist","company":{"id":5677,"name":"ICON","domain":"iconplc.com","url":"https://alion.io/company/icon","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":49,"ghost_share":0,"stale_share":0.98,"repost_share":0,"time_to_fill_p50_days":12,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Tokyo, Japan","Osaka, Japan"],"countries":["JP"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":42000,"max_usd":86000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":543},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-20T00:00:00Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-29T17:35:48Z","board_verified":true,"closed_at":null,"days_open":9,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":9},"description":"Senior Regulatory Scientist - Tokyo Osaka Home - Full remoteICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.\nAs a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.\nAs 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.\nWhat You Will Do:\nYou will take ownership of regulatory affairs deliverables, applying your expertise to complex challenges.\nKey responsibilities include:\nLeading or significantly contributing to regulatory strategy development for clinical programmes and key milestones.\nAuthoring and reviewing complex regulatory documents, including clinical trial applications, briefing documents, and major submission components.\nInterpreting global regulations, guidelines, and precedents and advising cross-functional teams on regulatory expectations and risk.\nParticipating in or leading interactions with health authorities, including meeting preparation, presentation support, and follow-up.\nProviding regulatory input into clinical development plans, risk management strategies, and labelling considerations.\nMentoring junior regulatory staff and contributing to internal standards, templates, and best practices.\n薬事関連資料（各種面談資料、治験届等）の作成\n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\n社内他部門との連携と薬事観点のアドバイス提供\n薬事戦略の提案やプレゼンテーション\n新規事業獲得にむけてクライアントへのアプローチ\nCMC関連文書作成・CMCコンサルティング全般\n業務関連通知・規制アップデートの全体共有 等\n※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。\nYour Profile:\nYou will have a strong foundation in regulatory affairs, with the experience to work independently and guide others.\nRequired qualifications and experience:\nBachelor's degree in a relevant scientific discipline or healthcare-related field\nSubstantial experience in regulatory affairs or regulatory science within pharma, biotech, or CRO.\nStrong understanding of global clinical development regulations and guidance (e.g., FDA, EMA, ICH).\nExcellent scientific writing, analytical, and critical-thinking skills, with meticulous attention to detail.\nProven experience supporting or leading health authority interactions and complex submissions.\nStrong communication and collaboration skills, with the ability to work effectively in cross-functional teams.\nWillingness to travel as required (approximately 5%)\n下記の業務のいずれかを3年以上経験していること\n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\n英語でのコミュニケーションスキル、文書作成能力\n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\nEmployment with ICON is contingent upon having the legal right to work in the country where the role is based.\nRewards & Benefits\nICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.\nBenefits may include:\nCompetitive base salary and performance related incentives\nHealth and wellbeing programmes including medical, dental, and vision coverage where applicable\nRetirement and pension plans\nLife assurance and disability coverage\nEmployee assistance programmes and wellbeing resources\nLearning and development opportunities through structured training and career pathways\nBenefits may vary depending on role and location.\nVisit our careers site to read more about the benefits ICON offers.\nInclusion and Accessibility\nICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.\nIf you require reasonable accommodations during the recruitment process, please let us know or submit a request here.\nAre you a current ICON Employee? Please click here to apply","description_format":"text","description_chars":3994,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"Japanese","level":"Advanced (C1)","optional":false}]},"benefits":["Retirement plans"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-10-22T02:26:09Z"}],"visa":[],"liveness":{"score":45,"band":"ok","label":"Likely open","p_open":1,"p_active":0.596,"p_room":0.75,"age_days":9,"expected_fill_days":12,"reasons":["conf:4","stale_co","velocity","win:late","comp:brand"],"computed_at":"2026-10-29T05:49:05Z"},"pay":null,"html_url":"https://alion.io/job/icon-senior-regulatory-scientist","json_url":"https://alion.io/job/icon-senior-regulatory-scientist.json","meta":{"generated_at":"2026-10-29T23:06:58Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":34165,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":5677},"rest":"https://alion.io/mcp/rest/get_company?id=5677"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ficon-senior-regulatory-scientist"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Ficon-senior-regulatory-scientist"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Ficon-senior-regulatory-scientist"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/icon-senior-regulatory-scientist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ficon-senior-regulatory-scientist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3050908}},{"tool":"search_jobs","arguments":{"company":"iconplc.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3050908},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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