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

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

This role supports the development and execution of medical strategies in Japan, leveraging nutrition science or biochemistry and/or pathologic nutrition or a related field, expertise to guide research planning and evidence generation. 
The position primarily supports Ultragenyx’s development stage and commercialized products in Japan. 

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Develop and execute medical strategies focused on the program’s mechanism of action, including dietary therapy–related mechanisms, within the field of metabolic disorders. 
2. Lead and provide scientific input to support field medical team and evidence generation from a metabolic disorders perspective.　 
3. Serve as a subject matter expert and strategic partner to Japan Medical Directors, leading the generation of  medical strategies as the biochemical and pathologic nutrition expert. 
4. Collaborates closely with Global Metabolic Nutrition Programs to ensure alignment of nutrition related scientific content and field communications.
5. Collect and share up to date scientific information on nutrition and metabolic disorders. 
6. Analyze and report findings from scientific literature and conference proceedings. 
7. Support the development of educational materials and internal training related to metabolic disorders. 
8. Ensure all activities comply with company policies, SOPs, and relevant compliance standards. 
9. Support scientific information exchange and insight gathering at congresses and external events as needed. 

Requirements:

1. Advanced degree (PhD or MS) in Nutrition Science, biochemistry and/or pathologic nutrition or a related field, with research experience required. 
2. Research experience in Nutrition Science and/or Biochemistry and/or metabolic disorders  
3. 3+ years post graduate experience in pharmaceutical industry, research or other relevant experience required. 
4. Clinical experience as a Registered Dietitian (e.g., patient counseling, nutrition management, or practical work in clinical settings) is preferred. 
5. Experience in rare diseases is a plus. 
6. Native level Japanese and business level English proficiency (reading, writing, and communication). 
7. Strong communication and teamwork skills to collaborate effectively with internal and external stakeholders. 
8. Demonstrated hands-on experience in analyzing, summarizing, and presenting scientific content. 
9. Ability to work independently and manage multiple priorities. 
10. Primarily remote or office based; able to support limited field activities (e.g., domestic travel and congress participation) as needed. 

#LI-CK1#LI-Remote

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

日本におけるメディカル戦略の立案・実行を支援し、栄養科学、生化学、病態栄養学、または関連分野の専門性を基盤として研究計画やエビデンス創出をリードする。 
国内でのUltragenyxの開発品および上市製品に対するメディカル活動を主たる責務として支援する。 

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. 代謝性疾患領域において、食事療法に関連するメカニズムを含むプログラムの作用機序（MOA）に焦点を当てたメディカル戦略を立案・実行する。 
2. 代謝性疾患の専門家として、フィールドメディカルチームおよびエビデンス創出活動を主導し、科学的方針およびインプットを提供する。 
3. 代謝性疾患の観点から、フィールドメディカルチームの活動およびエビデンス創出を支援するための科学的インプットを提供する。 
4. グローバル・メタボリック・ニュートリション・プログラム（Global Metabolic Nutrition Programs）と密に連携し、栄養に関連する科学的コンテンツおよびフィールドでのコミュニケーションの整合性を確保する。
5. 栄養科学および代謝性疾患に関する最新の科学情報を収集・共有する。 
6. 学術論文・学会発表の内容をレビューし、分析・要約・報告する。 
7. 代謝性疾患に関連する教育資材の作成および社内トレーニングを支援する。 
8. 社内方針およびSOP、関連コンプライアンス要件を遵守して、すべての活動を遂行する。 
9. （必要に応じて）学会や社外イベントでの科学情報提供・情報収集をサポートする。 

Requirements:

1. 栄養科学、生化学、病態栄養学のいずれか、または関連分野における高等学位（PhD または MS）を有し、研究経験を必須とします。 
2. 製薬業界、研究、またはその他の関連分野における大学院修了後3年以上の実務経験を必須とします。 
3. 管理栄養士としての臨床経験（患者指導、栄養管理、医療現場での実務等）があれば尚可とします。 
4. 希少疾患領域の経験が、あれば歓迎します。 
5. 日本語はネイティブレベル、英語はビジネスレベルの読解・文書作成・コミュニケーション能力を要します。 
6. 社内外ステークホルダーと円滑に連携できる高いコミュニケーション力およびチームワーク力。 
7. 科学的内容の分析・要約・資料作成およびプレゼンテーションに関する実務経験。 
8. 自律的に業務を進め、複数の優先事項を整理・管理できる能力。 
9. 原則リモートまたはオフィス環境で勤務しますが、業務上必要に応じて限定的な現場活動（国内出張、学会参加など）に対応できること。 

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Manager, Quality Assurance Japan, supports the Head of Quality Assurance Japan and leads day to day QA operations to sustain product launch and commercial activities. Partnering with CMC Quality, QC, Technical Operations, and Supply Chain, the role ensures operations aligned with Japanese GMP and GQP—while considering related GDP guidelines, GCP, and PV requirements—and supports the establishment of the local QA support model and supply chain model, providing technical assistance as needed. 

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Under the direction of the Head of Quality Assurance Japan, lead day‑to‑day execution of QA activities and contribute to on‑time completion.  
2. Support compliance with internal policies, SOPs, industry standards (GMP/GQP/GDP), and PMDA/MHLW notifications and guidance; support inspection readiness, day‑of activities, and drafting post‑inspection responses. 
3. Perform batch disposition (product release) in accordance with Japanese GQP requirements and support communications with regulators on quality matters. 
4. Oversee domestic product testing and visual inspection results, and promptly report any manufacturing, quality control, or product quality issues identified during batch disposition activities to the General Marketing Compliance Officer, the Head of Quality Assurance Japan, and relevant stakeholders. 
5. Author, revise, and implement SOPs and quality documents; support operation and continuous improvement of the QMS in line with corporate standards. 
6. Collaborate with CMC QA, QC, Technical Operations, Regulatory Affairs, and Supply Chain to ensure a safe, uninterrupted, and effective supply of products that meets patient and regulatory expectations. 
7. Execute and drive quality processes such as change management, deviations/CAPA, product quality complaint investigations, and product recall activities in collaboration with Global Quality. 
8. Draft and manage Quality Technical Agreements and, ensure their effective implementation, including support for GxP audits and supplier quality oversight of contracted partners such as CMOs, contract testing laboratories, and distributors.  
9. Provide QA support for artwork management and facilitate Japanese–English communications between domestic partners and global technical team. 
10. Participate in external collaborations to stay current with domestic policies, practices, and regulatory guidance, and work with CMC Leads and Portfolio Management to support effective project planning and execution. Perform other duties as assigned, as needed. 

Requirements:

1. Bachelor’s degree (or equivalent qualification) in a scientific discipline such as Pharmacy, Biology, Chemistry, or Biochemistry. 
2. At least 7 years of experience in the pharmaceutical or medical device industry, including at least 5 years in a quality organization within a regulated industry. 
3. Experience in product lifecycle management, with an understanding of development through commercialization for small molecules, biologics, and advanced therapies (e.g., gene therapy and mRNA). 
4. In-depth understanding of Japanese GMP and GQP regulations, GDP guidelines, and PMDA/MHLW laws, ordinances, and notifications. 
5. Experience in negotiating and managing quality agreements, as well as vendor relationship and performance management. 
6. Excellent written and verbal communication skills in both Japanese and English, with strong interpersonal skills to collaborate effectively within cross functional teams. 
7. Proficiency in the use of risk assessment and root cause analysis (RCA) tools. 
8. Experience applying quality systems and requirements across preclinical, clinical, and commercial stages. 
9. Strong planning, organizational, and time management skills, with the ability to prioritize and execute multiple projects in a fast paced environment. 
10. Ability to travel domestically and internationally, including Ultragenyx offices in Japan and the United States and vendor sites, as required. 

#LI-CK1 #LI-Remote

Position Summary:

Senior Manager, Quality Assurance Japan は、Head of Quality Assurance Japan と共に日本における品質保証（QA）オペレーションを実務面から支え、製品上市・商業活動を支えるために必要なライセンス維持をサポートします。CMC Quality、QC、テクニカルオペレーション、サプライチェーンと連携し、グローバル（および国内）の GMP・GQPを中心とし、関連するGDPガイドライン、GCP、PVなどの要件との整合を考慮した運営を確保します。また、経営陣および Head of Quality Assurance Japan と協働して、国内の QA サポートモデルとサプライチェーンモデルを整え、必要に応じて技術的支援を提供します。 

Responsibilities:

1. 日本国内の品質保証（QA）業務について、Head of Quality Assurance Japanの指示のもと実務遂行を主導し、期限内の完遂に貢献します。 
2. 社内ポリシー・SOP、業界標準（GMP／GQP／GDP）、PMDA／MHALの法令通知やガイダンス への準拠を監督し、査察対応（事前準備、当日対応、照会事項・指摘事項への回答作成を含む）を担当し、当局とのコミュニケーションを支援します。 
3. 日本のGQP要件に基づき、ロット判定（Batch Disposition） を実施し、品質関連事項について規制当局とのコミュニケーションを支援します。 
4. 国内における製品試験結果・目視検査等を監督し、出荷判定関連業務で把握した製造・品質管理・製品品質に関する不具合 を総括製造販売責任者、Head of Quality Assurance Japan、及び関係責任者へ速やかに報告します。 
5. Ultragenyx Japan の SOP・品質文書 を作成・改訂・運用し、コーポレート基準／品質システム に準拠した運用と継続的改善を推進します。 
6. CMC QA／QC／テクニカルオペレーション／薬事／サプライチェーン と連携し、患者および当局の期待に応える 安全で途切れのない有効な製品供給 を確保します。 
7. グローバル Quality と連携し、変更管理、逸脱／CAPA、品質苦情調査、製品回収 などの品質プロセスを支援・推進します。 
8. 品質契約（Quality Agreements／Quality Technical Agreements） を策定・管理し、委託先（CMO、外部試験機関、物流業者等）への GxP 監査支援／サプライヤー品質 を含め、効果的な実行を確保します。 
9. アートワーク管理 について、品質観点からを必要に応じて支援し、国内委託組織とグローバル技術チームの日本語コミュニケーション を円滑にするサポートを提供します。 
10. 外部コラボレーション へ参加し国内政策・実務・最新ガイダンスを把握するとともに、CMC リード／ポートフォリオマネジメント と協働してプロジェクトの計画・実行・成果達成を推進します。必要に応じて その他の業務 を遂行します。 

Requirements:

1. 科学系分野の学士号（薬学・生物学・化学・生化学など）または同等の資格。 
2. 製薬／医療機器業界での実務経験 7年以上で、かつ規制産業の品質組織での経験 5年以上。 
3. 製品ライフサイクルマネジメントの経験（低分子・バイオ医薬・先端治療〔遺伝子治療、mRNA〕の開発～商業化への理解）。 
4. 日本のGMP／GQP規制、GDP ガイドライン、PMDA／MHLWの法令・通知への深い理解。 
5. 品質契約の交渉・管理、およびベンダー関係・パフォーマンス管理の経験。 
6. 日本語・英語の優れた口頭／文書コミュニケーション能力と、チームで円滑に協働できる対人スキル。 
7. リスクアセスメントおよび根本原因分析（RCA）ツールの活用に習熟していること。 
8. 前臨床・臨床・商業の各段階に応じた品質システム／要件の適用経験。 
9. 変化の速い環境で、複数プロジェクトの優先付けと遂行ができる計画力・組織力・タイムマネジメント能力。 
10. 必要に応じて、 国内外のUltragenyxオフィス（日本／米国）やベンダー施設へ出張できること。 

Job title: Junior Business Analyst/ Business Analyst

Job Type: Permanent, full time

Reporting to: Business Analyst Manager

Location: Office based – Tokyo

Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health.

Our STEM team uses benchmarking through AI-enabled and evidence-based approaches to drive alignment resulting in accelerated performance. Serving clients across brand & commercial, Medical Affairs & sales, our expertise includes data, research & insights (proprietary benchmarking data), strategic brand alignment, and sales & MSL performance benchmarking. Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward. 

Job purpose:

We are looking for a highly analytical and data-driven graduate to join us in the business analysis team. The role will help you to develop a solid understanding of the pharmaceutical industry, strong quantitative and qualitative analytical skills, and to gain a unique insight into best practices across the industry.

As a member of the analysis team, you will have great visibility and exposure to senior directors in the company and the opportunity to take on a high level of responsibility for project delivery early-on in your career. You will be supported by an experienced analyst team through your development and training and be expected to collaborate and offer new insight within a close-knit team environment.

Key Responsibilities: 

• Managing multiple client projects and their timelines to meet both internal and client’s deadlines.
• Collaborating with Project leaders and other analysts to interpret data and formulate action plans and recommendations for clients.
• Analysing data from multi-sources using quantitative and qualitative methods to derive insights.
• Pressure testing data and identifying areas for investigation and training.
• Building and maintaining MS Excel databases from source data.
• Produce high quality presentations and other deliverables for clients using PowerPoint.
• Supporting members in the analysis team to meet client deadlines and drive development and efficiencies within the team both locally and on international projects.

Essential Requirements:

• The ideal candidate must have an Economics or Science based degree in subjects with numerical emphasis (such as Chemistry, Physics, Mathematics, Engineering etc.)
• A few years of experience in a similar analysis or sales job within the pharmaceutical industry is preferable.
• Strong communication and multi-tasking skills to handle multiple projects with different stakeholders.
• Advanced Level experience in using Excel and PowerPoint.
• Proactive individual with drive and ambition, a strong work ethic to grow in a dynamic environment with good opportunities to help develop and further the business as a whole.

About Ignite STEM:

Ignite STEM is a dynamic, fast paced global pharmaceutical and life sciences strategic benchmarking firm headquartered in the UK and present across six continents. STEM have developed an audit process and built a benchmarking database with more than 500,000 face-to-face observations completed across 52 countries. The benchmark provided is unique in the pharmaceutical industry consisting of over 100 KPIs, while focusing on 2-3 key priorities during formulation of action planning to help clients further accelerate performance.

STEM accelerates performance, improves strategic alignment, and facilitates excellence in marketing, medical, market access and account plans strategy execution. Due to the unique, specialised and highly targeted offering, STEM is experiencing a rapid growth phase, and recruiting heavily across the world. New employees will be joining at a time where rapid career development and growth opportunities are expected, as the organisation works towards their mid and long-term goals.

Vision:  To always be viewed as an essential partner in enabling our clients to reach more patients with their medicines

Mission: To accelerate high performance

Core Values: Brave, Honest, Performance Driven, Practical, Customer Focused, Caring

Find us here:STEM | Global Leader in Strategic Brand Alignment

Website: www.inizioignite.com. 

Ignite STEM  is an equal opportunity employer.  Ignite STEM will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. Ignite STEM only employs individuals with the right to work in the country/ies where the role is advertised.

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.