Opportunity

Brunswick is seeking an Account Director to join our Tokyo office to help domestic and international clients navigate financial, crisis and corporate communications.

Account Directors produce high quality advisory documents demonstrating a deep understanding of clients and issues. You will regularly be providing advice and analysis to clients, and developing an advisory voice informed by research, experience and awareness of market trends and events. You will manage some key workstreams as well as guiding Executives and Assistants on accounts.

As an Account Director, you will also begin to develop a network and build relationships with clients, media, advisers, Brunswick colleagues and other stakeholders. You will work to develop your media-handling skills and have a good understanding of Brunswick’s different sectors and specialist offers and how to connect them with clients as part of our one-firm offering.

About the Role

• Deliver media, political, regulatory and market analysis to clients, with intelligent insight and recommendations informed by data, analysis and experience.
• Manage the development of high-quality client documents, playing a key role in drafting, proofing, editing and version control, along with seamless project management of client workstreams.
• Guide Executives and Assistants in effectively supporting accounts.
• Develop a solid understanding of different sectors and specialist offers.
• Ensure all logistics for client meetings and events are executed smoothly and manage upwards to ensure Brunswick delivers on time and above expectation.
• Support on new business efforts and participate in pitch preparation.
• Begin to develop an advisory voice informed by research, experience and awareness of market trends and events.
• Nurture a network amongst peers inside and outside the firm, providing valuable insight for the firm and for clients.

What We're Looking For

• Highly knowledgeable on business issues and current affairs; up to date on international trends, issues, commentators and debates, particularly as it relates to financial services and corporate organisations.
• Fluent spoken and written English and Japanese (native level Japanese preferred)
• Strong written English
• An understanding of business, finance, and politics, with a genuine interest in communications.
• Able to demonstrate excellent written research and analysis for business audiences; must be able to synthesize large amounts of information across numerous sources in a timely but thoughtful manner.
• Proven project management experience, with the ability to oversee multiple fast-moving workstreams at any one time.
• A dynamic self-starter with a strong work ethic.
• High level of attention to detail and an intellectually rigorous, client-service attitude.
• An experienced team-worker who prefers to work in a collegiate way.
• Passionate to work in an international environment, strengthening Japan’s global engagement.

Why Join Us

Whether you are joining a client facing team, a core services team, or starting out on your professional career journey, joining Brunswick unlocks a range of  employee benefits to support your financial future, health and wellness, family and community and continuous professional development.

Our Benefits

• Annual Discretionary Bonus: Based on company and individual performance.
• Complimentary daily meals and refreshments — Enjoy breakfast, lunch, and unlimited all-day coffee and snacks, all provided in our on-site canteen and café.
• Generous Leave: 25 days’ annual leave plus an additional day for your birthday.
• Family Leave Policies: Maternity, Paternity, Shared Parental, and Adoption leave.
• Employee Assistance Programme: Support for your wellbeing.
• Headspace Membership: Access to mindfulness and meditation resources.
• Training Sessions: Lunch & Learn opportunities.
• Social Activities: Regular social, cultural, and charitable events.

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Associate Director of Regulatory CMC will lead and execute related chemistry, manufacturing and controls (CMC) regulatory activities/interactions under overall direction of Head of Regulatory Affairs Japan and/or VP, Global Regulatory CMC, and will help to develop regional regulatory CMC strategies for both established products and development products , serving as a key operational interface with global and regional teams.

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Contribute to the development and execution of the CMC regulatory strategies and lead day-to-day management of related regulatory activities for assigned programs. Under the guidance of the Head of Regulatory Affairs Japan and/or VP, Global Regulatory CMC, work with global and regional teams to develop and maintain project plans and timelines for pipeline of products, including coordination and support of global regulatory CMC submissions.  
2. Provide functional supervision and guidance to team members to ensure that all reporting requirements and other commitments are met with respect to Clinical Trial Notifications (CTN), NDAs, PCAs, MCNs, etc. while escalating issues and risks to the Head of Regulatory Affairs Japan and/or VP, Global Regulatory CMC, as appropriate. 
3. Provide regulatory advice and support for the global regulatory compliance of Ultragenyx pipeline of products including the evaluation of CMC related change controls, the strategic assessment of process and product comparability, their regulatory impact and implementation, with escalation of key risks and issues to the Head of Regulatory Affairs Japan and/or VP, Global Regulatory CMC as appropriate. 
4. Coordinate the preparation, review and filing of CMC sections of regulatory submissions and support interactions with regional regulatory agencies. 
5. Coordinate and oversee the preparation of regulatory CMC submission documentation to ensure that it is prepared with appropriate quality and within agreed timelines, in order to meet regional regulatory requirements and corporate objectives. 
6. Maintain and manage a centralized archive for tracking and monitoring the status of regulatory CMC commitments and agency reporting obligations, and prepare, generate and communicate status reports and other communication to the organization. 
7. Provide strategic and technical CMC regulatory support, guidance and expertise, and serve as the Regulatory Affairs Japan point of contact for CMC matters to global and cross-functional teams including Pharmaceutical Development, Quality Assurance, Quality Control, Manufacturing, contract organizations and consultants. Ensure, in alignment with the global regulatory strategy and under the guidance of the Head of Regulatory Affairs Japan and/or VP, Global Regulatory CMC, that all applicable regulatory requirements/options and associated risks are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines.  
8. Provide guidance and advice on regulatory CMC environments; provide assessment of the impact of new and changing regulations/requirements.  

Requirements:

1. BA/BS in a scientific field of study with 8 years + of relevant experience working in Regulatory in the pharmaceutical/ biotech industry. 
2. Strong knowledge, experience and the ability to provide technical guidance in interpretation of regulations and guidelines related to biological drugs and regenerative medicinal products development. 
3. Proven ability to analyze and organize information logically. 
4. Sound understanding and practical application of industry standards and international regulations and guidelines.  
5. Experience in clearly and effectively communicating regulatory strategies, submission documents and plans both internally and externally. 
6. The ability to effectively coordinate, manage and prioritize multiple projects in a fast-paced, deadline driven start-up environment.  
7. Strong collaboration, teamwork, organizational skills at attention to detail 
8. Excellent written and verbal English and Japanese communication skills. 

#LI-CK1 #LI-Hybrid

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Associate Director of Regulatory CMC – Japan は、Head of Regulatory Affairs Japan 及び／あるいはGlobal Regulatory CMCの指示に基づいて、化学、製造および管理（CMC）に関連する薬事業務および当局対応をリードし実行する。グローバルチームおよび地域チームとの主要な業務インターフェースとしての役割を果たしながら、既存製品および開発製品の双方について、地域の薬事CMC戦略の策定を支援します。 

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. 担当プログラムにおける CMC 薬事戦略の立案及び実行に貢献し、関連する薬事業務の日常的な推進を主導します。グローバルおよび地域チームと連携し、製品パイプラインのプロジェクト計画およびタイムラインを策定・維持するとともに、グローバルの薬事CMC申請の調整および実務的な支援を行います。 
2. Clinical Trial Notifications（CTN）、新薬承認申請（NDA）、承認事項一部変更承認申請（PCA）、軽微変更届（MCN）などに関する報告要件およびその他のコミットメントがすべて満たされるよう、他のメンバーに対して機能的な指導・管理を行い、指導・管理を行い、必要に応じて課題やリスクをHead of Regulatory Affairs Japan 及び／あるいはVP, Global Regulatory CMCにエスカレーションします。 
3. Ultragenyx の製品パイプラインに関するグローバル薬事コンプライアンスについて、助言および実務的な支援を提供し、CMC 関連の変更管理の評価、プロセスおよび製品の同等性に関する戦略的評価、それらの規制上の影響評価および対応の実行支援を行います。重要なリスクや課題については、適切に Head of Regulatory Affairs Japan 及び／あるいはVP, Global Regulatory CMCへエスカレーションします。 
4. 規制当局への申請に必要なCMC関連文書の作成、レビューおよび提出を調整し、地域の規制当局との対応を実務的に支援します。 
5. 地域の規制要件および企業目標を満たすため、CMC関連の薬事申請文書が適切な品質を確保し、合意された期限内に準備されるよう、管理調整を行います。 
6. CMC薬事コミットメントおよび当局への報告義務の状況を追跡・監視するための集中した文書管理を維持・管理するとともに、定められたプロセスに従い、状況報告やその他の情報を作成・発信し、関連組織に共有します。 
7. 製剤開発、品質保証（QA）、品質管理（QC）、製造、外部委託機関やコンサルタントなど、グローバルおよび各機能横断チームに対し、CMC薬事に関する戦略的かつ技術的なサポート、指針および専門知識を提供し、CMC領域におけるRegulatory Affairs Japan の窓口として対応します。また、グローバル薬事戦略に整合し、Head of Regulatory Affairs Japan 及び／あるいはVP, Global Regulatory CMCのガイダンスのもと、適用される規制要件や選択肢、および関連リスクを十分に考慮したうえで開発プログラムに適切に反映し、製品が適切な規制やガイドラインに準拠して開発・製造されるよう確保します。 
8. CMC の規制環境に関して指針や助言を提供し、新しい規制や要件の変更が与える影響を評価します。

Requirements:

1. 科学系分野の学士号（BA/BS）を取得しており、製薬・バイオテク業界における薬事関連業務で 8年以上の実務経験 を有すること。 
2. バイオ医薬品および再生医療等製品の開発に関する規制・ガイドラインの解釈について、高度な知識・経験を有し、技術的な指針や助言を提供できる能力を持つこと。 
3. 情報を論理的に分析し、体系的に整理できる能力を有すること。 
4. 産業基準および国際的な規制・ガイドラインについて、十分な理解を有し、実務に適切に適用できること。 
5. 規制戦略、申請文書、計画内容を社内外の関係者に分かりやすく、効果的に伝えた経験があること。 
6. 迅速で期限重視のスタートアップ環境において、複数プロジェクトを効果的に調整・管理し、適切に優先順位をつけて遂行できる能力 を有すること。 
7. 高い協働性、チームワーク、組織力、および細部への注意力を有すること。 
8. 優れた英語および日本語の文書・口頭コミュニケーション能力 を有すること。 

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Director, Regional Supply Chain Management for Japan acts as the representative for Global Supply Chain Management for all matters relating to the Japan region. This position focusses on building, implementing and executing the regional supply planning and distribution strategy in alignment with overall regional business strategy. The role oversees the distribution network and operations, regional demand, supply, operations and inventory planning, as well as ensuring successful product in-market product launches. 

This highly matrixed role closely liaises with many global and regional functions (Sales & Commercial, Packaging, Supply Planning, Medical Affairs, Clinical Operations, Quality, Finance and Tax), and represents the global supply chain in all Japan regional matters. This position also ensures compliance of the supply operations with local / regional regulations and global standards. 

The role may also act as a liaison between the local Japan management team and the wider Technical Operations group in the Japan region – including Global Packaging Operations and Global Product Supply.   

This position is a member of the Global Supply Chain leadership team and is located in Tokyo, Japan.  

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. As the Japan region grows, support all supply related activities in the region. Represent supply chain on the regional commercial management team.  
2. Build and oversee a reliable supply network in Japan for commercial distribution and support local clinical distribution activities including new product launch readiness as needed. 
3. Manage all local supply chain related activities including, but not limited to, order management, transportation, warehousing, inventory management and reporting, logistics and trade (import / export), and ERP transactions for Japanese product. 
4. Own the business relationship with all in country third party logistics providers. 
5. Alongside the local commercial team, oversee the regional Sales Inventory and Operations Planning (SIOP) for commercial launches, marketed products, early access programs and investigator sponsored trials. 
6. Develop annual budget plans and ensure supply chain costs in the region align with financial goals. Identify opportunities for supply chain related cost savings and implement solutions. 
7. Ensure compliance with regional regulations, GDP guidance, trade compliance and tax compliance in all areas of the regional supply chains 
8. Support for order processing operations from and to the wholesaler. 

Requirements:

1. Language: Fluency in both Japanese and English is required, both written and spoken, as well as understanding of local business norms in both countries. 
2. Education: A bachelor’s degree or local equivalent in a related field (Supply Chain, Business, Engineering). A master’s degree in business administration (MBA) is strongly preferred. 
3. Management experience: 8 or more years of experience in Supply Chain / Technical Operations in the pharmaceutical or biotech industries. Strong preference for project management and pharmaceutical launch experience as well as a certificate in Lean / Six-sigma training (green belt or higher). 
4. Pharmaceutical and regulatory experience: Understanding of pharmaceutical industry procedures and regulations including GxP and other regulatory requirements – particularly as it pertains to the local Japan market. Experience with new product introductions as it pertains to supply chain is preferred. 
5. Quality acumen: Familiarity with local and harmonized quality standards as they pertain to finished products and distribution. Experience operating in a pharmaceutical or biotechnology quality system and its related components (deviation, change control, etc…)    
6. Financial acumen and compliance: Understanding of regional and global commercial implications including SOX, tax regulations, international trade rules and trade compliance. 
7. Information technology: Hands on experience with the implementation and / or operation of a scalable enterprise resource system (ERP) such as Oracle, SAP or similar system. 
8. Travel: Ability and willingness to travel throughout Japan as needed as well as internationally (estimated four times per year), including travel to California. 

#LI-CK1  #LI-Hybrid

About the Teads Legal Commercial Team

The Teads Legal Commercial Team is a trusted legal partner to the global Teads business, providing high quality, business-centric advice and support. We are responsible for legal work supporting Teads’ revenue generating deals with our many clients and partners worldwide. We are a diverse team based out of various offices around the globe. 

About the Opportunity

The Teads Legal Commercial Team is seeking a highly motivated in-house commercial lawyer to join us in the role of Legal Counsel, Commercial.

This role is ideal for a lawyer with 3 to 5 years’ post qualification experience who enjoys being close to the business, solving real commercial problems, and building trusted relationships with stakeholders. You will work closely with our global business on various commercial and legal matters, including the full suite of Teads’ commercial agreements, legal operations and processes, and commercial data privacy, and be the primary point of contact for our Japan business teams. 

Reporting to the Head of Legal, Asia Pacific and Global Affairs, you should have strong collaborative and leadership skills to build credible business relationships with colleagues at all levels and champion a culture of growth, collaboration and accountability amongst fellow Teadsters that you work with.

What You Can Expect

As a Teadster, you will play a key role in enabling Teads’ future success in Japan and the world. You will be the trusted legal lead and business partner working closely and directly with business leaders and the Teads Legal Commercial Team on the following:

• Supporting Teads’ Japan and global commercial teams by managing, reviewing, drafting and negotiating all forms of commercial agreements, including but not limited to publisher, advertiser, agency and programmatic agreements, DPAs, NDAs and any other related agreements, work orders or questionnaires;
• Acting as a trusted legal adviser across a variety of legal matters in Japan and globally, including but not limited to matters relating to content compliance, commercial data privacy, sales and marketing enablement; 
• Supporting the global Legal Corporate team in areas of corporate governance, employment, intellectual property, employee enablement;
• Tracking legal, regulatory and industry body developments in Japan and key jurisdictions within your scope of responsibility, considering the impact on Teads’ business and advising accordingly;
• Supporting on establishing global and regional policies and guidelines in order to cultivate a scalable and risk/value-based approach, including but not limited to drafting, maintaining and updating contract templates, playbooks and other legal documents and policies;
• Supporting the management of contract life cycle processes and maintenance of records and related systems; and
• Contributing to internal training and knowledge sharing.

About You

Basic Qualifications

• LLB or JD from a reputable university
• Located in any of the following locations: Tokyo, Japan; Singapore; Kuala Lumpur, Malaysia; Hong Kong SAR; or Seoul, South Korea (ROK)
• 3-5 years of relevant in-house legal experience at a regional or global technology company, particularly in Japanese language commercial and technology transactions involving local business stakeholders. Previous or current in-house experience in one or more of the following industries is required: software, PaaS, SaaS, ICT or data-related services
• Familiarity with application of data privacy regulations to technology-related transactions in Japan. Similar knowledge in other Asia Pacific territories would be an advantage
• Native proficiency (written and spoken) in Japanese and English

Preferred Qualifications

• In-house experience in the following industries is ideal: Adtech, Media and Advertising, Digital Media
• Knowledge and experience in some or all of the following: advertising regulations, marketing regulations, information technology, corporate and finance law, corporate governance and compliance, intellectual property and/or employment law
• Excellent communication, influencing and negotiation skills, with the ability to drill into complex legal issues and make value-adding recommendations to senior management
• Adaptable and a master at prioritizing and time management
• Thrive in working as part of a dynamic global legal team
• Natural collaborator and a team player
• Proficiency in another language (written and spoken) within Asia Pacific

募集概要

商用運航開始（EIS）に向けた事業基盤構築、運航関連法規の適合性確保、およびカスタマーサポート体制確立のための統括をお任せします。 当局（国土交通省等）との折衝、型式証明における運航面の主導、および開発機の試験飛行等における運航コンプライアンスの保証を担うとともに、全社横断的なプロジェクト推進（PMO）機能として、事業計画の進捗管理と組織間の合意形成をリードいただくことを期待しています。

業務内容

 運航事業構築および全社プロジェクト推進 (Project Management & Operation Setup)

1. 商用運航開始に向けた全社マイルストーン計画の策定および進捗管理（PMO機能）
2. オペレーション構築に関わる各部門間の課題抽出・調整および意思決定の推進
3. 運航事業構築に関する戦略立案および実行指揮

法規・認証・開発機運航コンプライアンス (Regulatory Affairs & Development Compliance)

1. 航空法（省令・規程類含む）の調査検討、事業・開発への影響分析および対応方針の策定
2. 運航開始に必要な法規改訂に関わる社外折衝および当局調整の統括
3. 【開発機対応】 開発機の試験・実証飛行等における運航方法の策定、および法定搭載品の要件定義・適合性確認
4. 型式証明（TC）活動におけるF03（適合性証明計画）に基づくAFM（Aircraft Flight Manual）の作成・承認取得

訓練プログラムおよび運航標準の確立 (Training & Flight Standards)

1. FSB（Flight Standardization Board）活動を通じた乗員訓練要件の設定および認証取得
2. フライトシミュレーターおよび訓練装置の製作、認証取得、維持管理
3. パイロット訓練に必要な教材（Courseware）およびカリキュラムの開発
4. 次世代航空管制および運航方式に関する調査・検討

カスタマーサポートおよび技術支援 (Customer Support & Technical Services)

1. テクニカルパブリケーション（マニュアル類）の作成管理およびFSR派遣体制の構築
2. 顧客（エアライン等）向けの乗員・整備士養成訓練プログラムの提供
3. 機体引渡し支援および就航後の部品供給支援体制（サプライチェーン連携）の確立
4. AEG活動（航空機要件評価）を通じた、運航・整備面からの設計開発へのフィードバック

社内コミュニケーション (Internal Communication)

1. 法規改訂情報の社内発信および関係部門への啓蒙活動
2. 法規制遵守の文化醸成とステークホルダーマネジメント

必須スキル

• 10年以上の航空業界におけるご経験。また、運航標準、航空規制対応、整備士・操縦士訓練、またはカスタマーサポートに関する部署のマネジメント経験。
• 航空法、下部省令、および航空当局との折衝に関する深い知識と実務経験。
• 大規模なクロスファンクショナルプロジェクトを主導し、成功裏に完了させた実績。
• FSB/AEG活動、型式証明（特にF03/AFM）など、運航準備における専門的なプロセスに関する知識。
• 大卒以上（工学、航空学、経営学、または関連分野）。

求める人物像

• 経営陣のパートナーとして、全社視点からリスクとスピードのバランスを判断できる方
• 高度な技術開発を行うエンジニア組織への理解と、それを支えるバックオフィスへの情熱がある方
• 自らもハンズオンで動きつつ、組織としての再現性を高める仕組み作りが得意な方
• 課題を引き出し,その課題解決に向け自発的に考え,提案・実行に移せる方  
• 社内外問わず,あらゆる関係者と柔軟にコミュニケーションが取れる

雇用形態

• 正社員、もしくは契約社員
• 試用期間：あり（6か月）

勤務地

• 東京オフィス（東京都千代田区平河町一丁目3番13号   平河町フロントビル3階）
  
  • 受動喫煙対策：敷地内禁煙
• 県営名古屋空港ターミナルビル（愛知県西春日井郡豊山町大字豊場）
  
  • 受動喫煙対策：喫煙専用室設置
• ご希望に応じて初任勤務地を決定致します。
  • 初任勤務地が「東京オフィス」の場合は、基本的にはリモートワークとなります
• 必要に応じて出張が発生します。
• 変更の範囲：会社の定める場所 (テレワークを行う場所を含む)

勤務時間

• 管理監督者：
• 基本の勤務時間：9:00 ～ 18:00 （休憩60分）
• 時間外労働：有

休日

• 年間休日115（土・日、年末年始、会社指定）
• 有給休暇※入社月により付与日数は変動します。（会社規定に準ずる）

給与

• 想定年収：1100万円 - 1600万円
  月給：917,000円 ~ 1,334,000円
  固定残業報酬：20時間、 27,710 円 ~   38,855円を支給
  超過した時間外労働の残業時間代は追加支給
  スキル、経験、能力を考慮の上、決定

福利厚生

• 通勤手当、出張手当、単身赴任手当、引越し手当、他
  ※諸条件あり

加入保険

• 健康保険、厚生年金、雇用保険、労災保険

業務内容変更の範囲

• 全ての業務への配置転換あり

Oversee the construction of business infrastructure for Entry Into Service (EIS), ensure conformity with operational regulations, and establish the customer support structure. This role is responsible for negotiations with authorities (such as the Ministry of Land, Infrastructure, Transport and Tourism), leading the operational aspects of Type Certification, and guaranteeing operational compliance for development aircraft test flights. Additionally, the role acts as a company-wide Project Management Office (PMO) to lead business plan progress management and organizational consensus building.

What You'll Do

1. Project Management & Operation Setup

• Formulate company-wide milestone plans for the commencement of commercial operations and manage progress (PMO function).
• Promote issue extraction, coordination, and decision-making across departments regarding the construction of operations.
• Formulate strategies and direct execution regarding the establishment of the flight operations business.

2. Regulatory Affairs & Development Compliance

• Investigate and examine Aviation Law (including ministerial ordinances and regulations), analyze the impact on business and development, and formulate response policies.
• Oversee external negotiations and adjustments with authorities regarding legal revisions necessary for commencing operations.
• [Development Aircraft Support] Formulate operational methods for testing and demonstration flights of development aircraft, and define requirements and confirm conformity for legally required onboard equipment.
• Create and obtain approval for the Aircraft Flight Manual (AFM) based on F03 (Conformity Certification Plan) during Type Certification (TC) activities.

3. Training & Flight Standards

• Set crew training requirements and obtain certification through Flight Standardization Board (FSB) activities.
• Manufacture, obtain certification for, and maintain/manage flight simulators and training devices.
• Develop courseware and curricula necessary for pilot training.
• Investigate and examine next-generation air traffic control and flight operation methods.

4. Customer Support & Technical Services

• Create and manage technical publications (manuals) and establish the dispatch structure for Field Service Representatives (FSR).
• Provide crew and mechanic training programs for customers (airlines, etc.).
• Establish support for aircraft delivery and post-entry-into-service parts supply support systems (supply chain coordination).
• Provide feedback to design and development teams from operational and maintenance perspectives through Aircraft Evaluation Group (AEG) activities.

5. Internal Communication

• Disseminate information regarding legal revisions internally and conduct awareness activities for related departments.
• Foster a culture of regulatory compliance and manage stakeholders

What We're Looking For

•  Experience: Over 10 years of professional experience. Of this, at least 5 years must be senior management experience in the aviation industry (commercial airlines, emerging aviation mobility companies, etc.) related to flight standards, regulatory compliance, training, or technical support.
• Regulatory Knowledge: Deep knowledge and practical experience regarding Aviation Law, subordinate ministerial ordinances, and negotiations with aviation authorities.
• Project Management: A proven track record of leading and successfully completing large-scale cross-functional projects.
• Technical Processes: Knowledge of specialized processes in operational preparation, such as FSB/AEG activities and Type Certification (particularly F03/AFM).
• Education: Bachelor’s degree or higher (Engineering, Aeronautics, Business Administration, or related fields)

Skills for Collaborative Success:

• An individual who thinks proactively and can advance tasks in consultation with their supervisor.
• A proactive person with the initiative to engage and drive progress on the ground.
• Someone who can communicate smoothly with stakeholders.
• An individual with strong problem-solving skills, logical thinking, and execution capabilities.
• A flexible individual who can adapt approaches based on the situation, not limited by past successes or precedents.
• Someone capable of incorporating others' opinions and ideas while driving tasks towards achieving objectives.
• A person with a great personality, proactive in communication with stakeholders, and a positive attitude towards work.

Type of Employment

• Permanent Employee or Contract Employee
• Probationary period: 6 month

Place of Employment

• Tokyo Office: Hirakawacho Front Building 3F, 1-3-13 Hirakawacho, Chiyoda-ku, Tokyo
  • Measures to Prevent Secondhand Smoke:No smoking on the premises
• Nagoya Airport Office: Nagoya Airport Terminal Building 2nd floor, Toyoba, Toyoyama-Cho, Nishikasugai, Aichi Prefecture
  • Measures to Prevent Secondhand Smoke: Smoking Room Provided
• Initial work locations will be determined based on your preference.
  • If your initial location is the Tokyo Office, the role will primarily be remote.
• Please note that business travel may be required as needed.
• Scope of Change: Places determined by the Company (including places where telework is performed)

Working Hours

• Managerial Supervisors
• Basic working hours: Start 9:00　End 18:00（Including 1hour break time）

Holidays

• 115 days off per year（Saturday / Sundays / Newyear holidays（12/29～1/3） / Company designated holidays）
• Annual paid leave
• Refresh leave (Granted after 1, 3, 4, 5 years of service)

Salary

• Estimated Annual Salary: JPY 11,000,000 - JPY 16,000,000
• Monthly Salary: JPY 917,000 - JPY 1,334,000
  • Includes fixed overtime pay for 20 hours, amounting to JPY 27,710 - JPY 38,855
    *Additional overtime pay will be provided for hours exceeding the fixed overtime.
• To be determined based on skills, experience, and abilities

Expenses

• Commuting allowance, business trip allowance, moving allowance, etc.
• Relocation Packages
  *There are some conditions.

Social Insurance

• Health insurance
• Employee pension (according to Japan standards)
• Employment insurance
• Worker’s accident compensation insurance

Scope of Work Change

• Reassignment may occur to any other work.

Position Summary

The Device Regulatory Senior Manager will work together with Global Regulatory Affairs to lead the regulatory strategy and documentation management from Device product perspectives to facilitate the submission processes for the development, approval, and commercialization of medical devices in the U.S. and other global market. This position requires a deep understanding of FDA regulations, as well as expertise in navigating the requirements of medical device development and regulatory compliance. The ideal candidate will ensure timely and successful regulatory submissions, manage relationships with regulatory agencies, and provide strategic guidance to cross-functional teams, including Regulatory Affairs department at Rakuten Medical.

Key Roles and Responsibilities

• Develop and Implement Device Product Regulatory Strategy: Create and execute regulatory strategies for new product development, approval, and lifecycle management, ensuring alignment with company goals and regulatory requirements including U.S. FDA, CE marking.
• Regulatory Submissions: Oversee and prepare high-quality regulatory submissions (e.g., 510(k), PMA, IDE, and De Novo applications) and manage the process from pre-submission meetings to final approvals.
• Regulatory Compliance and Documentation: Ensure compliance with U.S. FDA regulations (21 CFR Part 820), Quality System Regulations (QSR), CE marking and other applicable guidelines and standards (ISO 13485).
• Regulatory Intelligence and Risk Assessment: Conduct regulatory assessments and stay updated on changes in requirements, e.g., FDA regulations and guidance, analyse their impact on current and future projects.
• Cross-functional Collaboration: Provide regulatory guidance and training to R&D, clinical, marketing, and quality teams to integrate regulatory requirements into product development and commercialization plans.
• Agency Interaction: Work with Global Regulatory Affairs to serve as the liaison with the FDA and other regulatory agencies, managing agency interactions, responses to inquiries, and ongoing regulatory requirements.
• Team Leadership: Work with Global Regulatory Affairs and Device Technical team to establish best practices and maintain high standards in regulatory processes.

Desired Education, Skills and Experience

• Education
  • Bachelor’s Degree in Life Sciences, Engineering, or a related field.
  • Advanced Degree (Master’s, Ph.D., or JD) in Biomedical Engineering, or a relevant scientific discipline is preferred.
• Skills/expertise
  • In-depth Knowledge of Medical Device Regulations & Requirements, including FDA Regulations. Strong expertise in 21 CFR Part 820 (QSR), ISO 13485, and FDA guidance on medical devices.
  • Technical Writing and Documentation: Exceptional skills in preparing regulatory documentation and understanding technical data for submission.
  • Analytical and Strategic Thinking: Ability to assess regulatory risks, interpret regulatory requirements, and develop actionable strategies for complex regulatory challenges.
  • Project Management: Strong organizational skills with the ability to manage multiple projects and meet regulatory deadlines.
  • Leadership and Communication: Demonstrated leadership skills with the ability to communicate effectively with cross-functional teams and regulatory agencies.
  • Regulatory Certification (Preferred): RAC (Regulatory Affairs Certification) or equivalent certification is a plus.
  •  Preferred skills:
    • Familiarity with global regulatory requirements, including EU MDR, MDSAP, and other international regulatory frameworks.
    • Knowledge of emerging regulatory trends and digital health regulations, including software and AI-based medical devices.
    • Experience with investigational device exemptions (IDEs)
    • Experience in communicating in English with business partners and the ability to read, write, and speak in English is required
• Experiences
  • 10+ years of experience in regulatory affairs, 5+ years within the medical device industry, with a strong focus on the regulation requirements in major jurisdictions, e.g., U.S. FDA, CE marking.
  • Proven track record of successful regulatory submissions and product approvals in the major jurisdictions (e.g., 510(k), PMA).
  • Experience with Class III or higher medical devices is preferred; familiarity with combination products or software as a medical device (SaMD) is a plus.
  • Experience in managing cross-functional projects.

Required Documents:

Please submit your resume (履歴書and職務経歴書) in Japanese and CV in English.