Tokyo, Japan · On-site
Basic Function The Regulatory Manager plays a critical role in developing and executing regulatory strategies for new product development, including OTC drugs, quasi-drugs, Foods with Functional Claims (FFC) and cosmetic…
Skills: Regulatory Strategy, Japanese Regulatory Frameworks, Health Authority Interaction, Project Management, Compliance Review
AbbottTokyo, Japan · On-site
JOB DESCRIPTION: JOB DESCRIPTION Title: Legal Director, Japan Location: Tokyo, Japan PRIMARY JOB FUNCTION The Legal Director's primary role will be to provide legal advice and direction to all business divisions in Japan…
Skills: Legal Advice, Risk Assessment, Compliance, Commercial Law, Privacy Law
Tokyo, Japan · On-site
Who We Are Applied Materials is a global leader in materials engineering solutions used to produce virtually every new chip and advanced display in the world. We design, build and service cutting-edge equipment that help…
Skills: Employee Relations, Investigations, Performance Management, Labor Law, HR Compliance
Tokyo, Japan · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office, Warehouse Job Description Essential Duties and Responsibilities Understand key business drivers and leverage knowledge of the regulatory framework and env…
Skills: Team Management, Leadership, Communication, PMD Act Knowledge, Regulatory Strategy
Tokyo, Japan · On-site
Job Description: Business Overview The Technology Management Division (TMD) provides corporate IT, cyber security, and privacy governance to Rakuten Group companies and essential business management for technology organi…
Skills: Privacy Law Compliance, GDPR, Privacy Impact Assessments, Contract Review, Data Breach Response
Tokyo, Japan · Hybrid
Let’s be #BrilliantTogether Overview ISS STOXX is growing! We seek a Research Analyst to join our Global Research team based in Tokyo, Japan. In this role, your focus is on corporate governance research- to translate and…
Skills: Japanese Language Proficiency, English Language Proficiency, Corporate Governance Research, Financial Analysis, Microsoft Excel
Tokyo, Japan · On-site
Company Description PSI is a leading full-service global Contract Research Organization providing a wide range of clinical trial services to the pharmaceutical and biotechnology industry, mainly for the development of cl…
Skills: Contract Drafting, Contract Negotiation, Legal Advice, Compliance, Legal Research
White & Case LLPTokyo, Japan · On-site
The Associate Track role is composed of early-career roles on the legal pathway. Roles at this level focus on gaining practical legal experience, often across a variety of law specialisms. Likely to be actively working t…
Skills: Legal Research, Document Drafting, Case Management, Analytical Skills, Legal Writing
Tokyo, Japan · Hybrid
Job Description: At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. We do this by driving Responsible Growth and delivering for our clients, t…
Skills: Series 16 Registration, Compliance Review, Financial Services Knowledge, Analytical Abilities, Communication Skills
Tokyo, Japan · On-site
Join our team and support operational risk and regulatory compliance controls across multiple businesses through a job rotation. As an Associate Location Control Manager within the Control Management, you will report to …
Skills: Operational Risk Control, Regulatory Compliance, Business Management, Financial Analysis, Problem Solving
Tokyo, Japan · On-site
会社概要 シンジェンタは「植物のちからを暮らしのなかに」という企業目的のもと、気候風土や食文化の異なる90カ国以上の地域で事業を展開しています。多種多様な農業に適応することで得た知識と技術を活用し、大切なパートナーの皆様とともに日本の農業の発展に貢献してまいります。 私たちは世界規模で事業を展開し、増大を続ける食糧需要に応えています。 シンジェンタジャパンは、ワールドクラスの人材と製品によって世界の各地で農業に貢献し、新しい価値を創造し…
Skills: Regulatory Affairs, Biotechnology, Genetically Modified Crops, Genome Editing, Regulatory Compliance
Tokyo, Japan · On-site
会社概要 シンジェンタは「植物のちからを暮らしのなかに」という企業目的のもと、気候風土や食文化の異なる90カ国以上の地域で事業を展開しています。多種多様な農業に適応することで得た知識と技術を活用し、大切なパートナーの皆様とともに日本の農業の発展に貢献してまいります。 私たちは世界規模で事業を展開し、増大を続ける食糧需要に応えています。 シンジェンタジャパンは、ワールドクラスの人材と製品によって世界の各地で農業に貢献し、新しい価値を創造し…
Skills: Regulatory Affairs, Biotechnology, Project Management, Scientific Communication, Compliance
Tokyo, Japan · Hybrid
職務概要 Clarivateは、イノベーションとコラボレーションに注力するグローバルリーダーとして、プロフェッショナルとしても個人としても成長できる環境を提供しています。柔軟なハイブリッドワーク制度により、ワークライフバランスを重視しながら効率的に働くことが可能です。東京オフィスは18階に位置し、都心の美しい景色を望めるだけでなく、創造性とチームワークを促進する魅力的な環境です。多様で先進的な組織の一員として、ともに未来を創っていきませ…
Skills: Patent Search, IP Analytics, Project Management, Business English, Requirements Definition
Tokyo, Japan · Hybrid
雇用機会 お客様は私たちにとって最も重要であり、多くのエンドユーザーは私たちの製品・サービスを信頼して安心した日々をおくることが出来ています。私たちのビジネスの将来のために、重大な問題を解決して価値を提供することが出来るレギュラトリー・コーポレートコンプライアンス部マネージャーを求めています。 The Opportunity The customer is the focus of everything we do, and milli…
Skills: Compliance Framework Design, Regulatory Review, Risk Monitoring, Data Analysis, Presentation Skills
Tokyo, Japan · On-site
As Account Support Executive, You play a vital role in supporting the end-to-end deal lifecycle within a designated sales territory, overseeing deal progress, ensuring timely execution, and acting as a key liaison betwee…
Skills: Deal Structuring, Contract Redlining, Sales Operations, Account Coordination, Japanese Fluency
Tokyo, Japan · On-site
As Account Support Executive, You play a vital role in supporting the end-to-end deal lifecycle within a designated sales territory, overseeing deal progress, ensuring timely execution, and acting as a key liaison betwee…
Skills: Deal Structuring, Contract Redlining, Sales Operations, Account Coordination, Japanese Fluency
Tokyo, Japan · Remote OK
Company Description PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a g…
Skills: Clinical Trial Submissions, PMDA Regulations, Regulatory Dossier Preparation, English Proficiency, Japanese Proficiency
Tokyo, Japan · Hybrid
Site Contracting - Tokyo Osaka - Office Hybrid Home 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 values-dr…
Skills: Contract Management, Contract Negotiation, Regulatory Compliance, Risk Analysis, Contract Drafting
Tokyo, Japan · Hybrid
Job Title Senior Account Executive About the Role We are seeking an experienced professional to serve as our Responsible Officer for Management (Keio‑Gyomu‑Kanri‑Sekininsha) under the Construction Business Act of Japan. …
Skills: Regulatory Compliance, Corporate Governance, Financial Oversight, Operational Governance, Construction Business Act
BiogenTokyo, Japan · Hybrid
Job Summary: 特定のプロジェクトチームの日本の薬事担当者として、薬事戦略の策定及び実施に積極的に貢献し、必要に応じて関連する規制当局と交渉を行う役割を担う。 日本のライフサイクルマネジメントを含め、新薬の承認申請資料の作成プロセスを管理する。 Job Duties: 規制に関する十分な知識に基づき、開発の全段階（第I相以前から市販まで）において担当するプロジェクトやプログラムの薬事戦略の策定と実施に積極的に貢献する責任を負う…
Skills: Regulatory Strategy, Regulatory Affairs, Lifecycle Management, Regulatory Negotiation, Submission Management
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Develop and execute regulatory strategies for new product development including OTC drugs, quasi-drugs, and cosmetics. Lead interactions with health authorities and ensure compliance of advertising and labeling materials.
Requires a Bachelor's degree in Pharmacy, Science, or a related field with at least 5 years of experience in Regulatory Affairs. Must have in-depth knowledge of Japanese regulatory frameworks and native-level Japanese proficiency.
Basic Function
The Regulatory Manager plays a critical role in developing and executing regulatory strategies for new product development, including OTC drugs, quasi-drugs, Foods with Functional Claims (FFC) and cosmetics. The position works closely with global teams, internal stakeholders, and external partners to contribute to business growth and enhance the quality of regulatory operations.
Scope of Responsibilities
● Develop and execute regulatory strategies for new product development, including Rx-to-OTC switches and product innovations.
● Lead regulatory activities for life cycle management of assigned products.
● Review and approve advertising materials, promotional content, and labeling to ensure regulatory compliance and appropriate claims.
● Lead negotiations and interactions with health authorities (such as the Ministry of Health, Labour and Welfare, PMDA, local government pharmaceutical divisions, and the Consumer Affairs Agency), including consultations, submissions, and responses to inquiries.
● Prepare and review regulatory documents (such as consultation materials, application dossiers, and inquiry responses) to ensure accuracy and compliance.
● Collaborate with cross-functional teams (Marketing, R&D, etc.) and global teams to ensure strategic alignment and smooth execution.
● Collect, analyze, and share regulatory intelligence; assess business impact and risks.
● Build and maintain strong relationships with external stakeholders, including trade associations and regulatory authorities.
● Provide guidance and coaching to Regulatory Specialists to enhance team capability.
● Actively participate in internal planning initiatives and cross-functional projects to support business objectives.
Knowledge, Skills and Abilities
● In-depth understanding of Japanese regulatory frameworks (Pharmaceuticals and Medical Devices Act, labeling regulations, FFC-related regulations).
● Experience in health authority interactions and regulatory submissions.
● Strong communication, negotiation, and coordination skills.
● Ability to collaborate effectively with global teams and external stakeholders.
● Project management skills.
● Native-level Japanese proficiency (written and spoken).
● Business-level English proficiency (written and spoken) is preferred; however, candidates with strong practical experience and expertise will be considered with flexibility on English requirements.
Education / Experience
● Bachelor's degree or higher in Pharmacy, Science, Agriculture, Life Sciences, or related fields.
● Minimum 5 years of experience in Regulatory Affairs (experience in OTC drugs and quasi-drugs preferred).
● Proven experience in team leadership or project leadership within regulatory functions.
● Experience working with global teams is a plus.
Industry-related activity experience preferred.
Health. In Your Hands.
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission on our website.
There are currently 152 open legal positions in Tokyo, Japan listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Rakuten, AlixPartners, JPMorganChase, PSI CRO, Sanofi, among others. Browse the listings above to see every active employer.
Yes — 70 of the 152 open legal positions offer remote or hybrid work (5 remote, 65 hybrid).
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