Jobs list of Pharmaceutical & Regulatory Affairs
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Job number: JN -102025-194797 Posted: 2025-10-08
医薬事業開発担当
ヘルスケア業界において他社との交渉をまとめ上げた経験や協業をリードしたご経験をお持ちの方必見です6.45 - 10.61 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- We specialize in the research, development and manufacture of pharmaceutical products. We mainly provide therapeutic drugs for diseases of the cardiovascular system, bone and joint system, and nervous system, with the aim of improving the health and quality of life of patients. We are committed to creating new drugs and improving existing drugs by utilizing our advanced technological and R&D capabilities. We also set strict standards for product quality control to supply safe and effective medicines to the market. In collaboration with medical and research institutions in Japan and overseas, we also focus on developing treatments that incorporate cutting-edge medical technologies. With an emphasis on a patient-centered approach, we have established ourselves as a trusted pharmaceutical manufacturer.
- Responsibilities
- グローバル展開する同社の医薬品提携業務として、アライアンスマネジメント業務または医薬品ライセンス業務での中心的な役割を果たしていただきます。具体的な業務:
１．アライアンスマネジメント業務（1）提携先との交渉提携後に必要な各種契約の交渉、締結
契約外の事象の取り扱いに関する交渉
（2）提携先との会合の主催各提携品目について年間1～2回開催される運営委員会を主催
各提携品目について週1回～月1回の頻度で開催される定期的な打ち合わせを主催（開発、製造関連のものを含む）
上記の会合のための社内外調整と当日のファシリテーション
（3）社内各部署と提携先との協業サポート自社および提携先の各部署間で開催する打ち合わせへの参加
各部署が主体で締結する契約書のレビューに参加
各部署が契約に基づいて業務を遂行できるように助言、問い合わせへの対応
（4）提携品目に関わる社内対応各種契約の締結に際する決裁対応
中期経営計画、ライフサイクルマネジメントの議論への参加
２．医薬品ライセンス業務（1）導入対象品目の選定社内関係部署と導入戦略、導入領域の立案・選定
導入対象品目へのアプローチ
マッチングカンファレンスにおける案件探索
（2）導入対象品目の評価社内関係部署を用いて案件の科学的評価、事業性評価、当社適合性評価、競合分析等
評価結果を基に導入判断
（3）導入契約の契約交渉、締結Capability Presentation等の社内取りまとめ、先方提示等のマネジメント
ビジネススキームの検討、提案
契約交渉、及びそれに伴う社内関係部署との調整
Yui Osone
Industrial & Life Science -
Job number: JN -072024-143843 Posted: 2025-10-03
Medical Writer
Medical Writer8 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people\'s health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.
- Responsibilities
- Preparation of investigational drug summary (IB)
Preparation of a general report (CSR)
Creation of Approval Application Material (CTD) Clinical Part
Preparation of draft package insert (clinical part) for development products
Preparation of face-to-face advice (pre-application consultation) materials
Creating answers to inquiries regarding clinical parts after application for approval
Publication of clinical trial results on the clinical trial information registration site
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -092025-194319 Posted: 2025-09-26
マスターファイル登録・審査対応
ビジネスメールにて基本的な対応が可能なレベルの英語力を有する方必見です8 - 11 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- We are a company that offers a diverse range of products and services, including chemicals, plastics, electronic components, machinery and equipment, and food products. With a long history and based on strong relationships with our customers and partners, we are expanding our business both domestically and internationally. We also focus on technological development and environmental initiatives, actively contributing to the realization of a sustainable society. In a wide range of industrial fields, we are continuously growing to meet the diverse needs of our customers by leveraging our expertise and flexible response capabilities.
- Responsibilities
- 入社後の主な担当領域入社後は、既存マスターファイルの維持管理に加え、長期収載品に関する原薬のマスターファイル登録および審査対応をご担当いただきます。
また、新規の後発医薬品に関する原薬についても、マスターファイルの登録と審査対応業務をお任せいたします。
加えて、当社における医薬品製造業（表示・保管）に関するGMP業務（製造管理および品質管理業務）の支援業務をご担当いただく可能性がございます。
将来的な業務展開中長期的には、ご本人の希望や適性を踏まえながら、原薬関連のレギュラトリ業務に加え、化粧品や食品に関するレギュラトリ業務、さらには海外地域におけるレギュラトリ業務にも取り組んでいただく可能性があります。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -092025-194043 Posted: 2025-09-18
CMC（マネージャー）
英語 （海外拠点とのコミュニケーション力）をお持ちの方必見です8.4 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client is manufactures and sells pharmaceutical products.
- Responsibilities
- 開発プロジェクトや既存上市品の改善プロジェクト等に参加・サポート
新薬申請や一変申請／軽微変更届においてはCTD、承認申請書の作成において、品質試験関連の責任をもつ。
規制当局（PMDA 等）照会対応・申請戦略支援
上市品の逸脱・品質クレーム・変更管理サポート
新規CMOへの製造委託、製品の立ち上げに関して、分析技術の責任技術者としてCDMOサポート
試験委託や分析法移管に関して、責任技術者として試験委託や移管をリード
治験薬供給において、SOPの作成整備、治験薬品質管理責任者として委託先CDMOの品質試験関連の監督
不純物評価（含：遺伝毒性不純物、抽出溶出など）の実務統括
CMCマネジメント業務で発生する書類の管理、薬物管理
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -082025-193322 Posted: 2025-08-29
開発企画部
医薬品業界でのご経験の方必見です5 - 7 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client primarily manufactures and sells prescription pharmaceuticals and in-vitro diagnostic reagents.
- Responsibilities
- CMC担当者として、同社製品の開発に関するCMC戦略の立案及び承認申請業務を担っていただきます。製造及び試験手順の理解に基づくCTD作成（主にCMC）、及び紹介対応
海外の関係会社/研究機関との協業における資料提出期限や品質の確保
海外の関係会社/研究機関とのコミュニケーション（医薬品の海外導出）
DMFの作成、変更対応
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -082025-193087 Posted: 2025-08-25
CMC薬事担当
バイオ医薬品・ワクチンのグローバル申請・承認取得・変更申請に従事したご経験をお持ちの方必見です6 - 10 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
- Responsibilities
- 医薬品の開発段階から承認取得、さらに市販後変更管理に渡る関するグローバルCMC薬事戦略の立案と日本・アジア・太平洋地域におけるCMC薬事業務の推進、資料作成、当局対応、等の業務全般を担当する（実際に担当いただく業務は、採用決定後に配属グループ内で調整し決定される）。 実務のリーダー的役割を担い担当業務を推し進める。複雑な課題に対して専門知識を活かして自律的に解決方法を検討し、実務経験や前例も考慮した判断を行う。複雑な情報を明確に説明し、困難な状況でも合意形成を図りながら、与えられた裁量を最大限に活用し、チームの成果を最大化する。 社内業務プロセスの改善点を特定・提案しながら問題解決や効率化を図る。業務を通じて高い組織成果の創出と後進の育成に貢献し、プロフェッショナルとしての自らの成長を組織の成長に活かす。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -082025-192755 Posted: 2025-08-20
管理担当
製薬企業でのQA、RA、CMO管理等の業務において、市販後CMC変更管理に関わる業務経験をお持ちの方必見です11 - 15 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
- Responsibilities
- 市販後CMC変更管理に対する、①製造所等から提案される変更案件のリスト化、および薬事評価要否検討②上記の薬事評価要否検討結果に対する関係部所との協議、合意形成③各変更が最終的に紐づく製剤ロット、および市場出荷時期の可視化④各変更の承認希望時期の設定、および関係部所への情報提供⑤変更案件の薬事対応ステータス、および影響を受ける製剤ロットの確認
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072025-192087 Posted: 2025-08-15
ライセンシング
商談可能な英会話力をお持ちの方必見です6 - 9 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client is a new drug manufacturer.
- Responsibilities
- ライセンス（主にライセンスイン）に関連する業務候補製品、新規プロジェクトの探索
候補製品、新規プロジェクトの初期評価
プロジェクトの事業性評価
提携主要条件交渉、社内外合意形成
海外提携先との窓口業務
社内関連部門とのプロジェクトのコーディネートと推進※当面は実務業務がメインですが、本人の希望や能力に応じ、将来的にはマネジメント業務も検討可能です。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -052025-188683 Posted: 2025-08-15
Regulatory Affairs Specialist
Tokyo or Osaka OK8 - 10 million yen Osaka Pharmaceutical Regulatory Affairs
- Company overview
- Leading global CRO company
We provide drug discovery, development, lifecycle management and laboratory services.We are a company that provides services related to drug development. We are responsible for the collection and analysis of clinical trial data for pharmaceutical products, support for regulatory filings, and quality control. Our team of experts provides tailored solutions to ensure the safety and efficacy of our clients\' needs. We are focused on providing high quality services in compliance with strict regulations. We provide professional support with our experience and knowledge to help our clients succeed in drug development. - Responsibilities
- Main responsibilities:
Work related to the preparation, maintenance, and management of clinical trial applications and attached documents
Various consultations with regulatory authorities (PMDA, MHLW, etc.)
Work related to approval applications (support for client applications)
Work related to the collection, maintenance, and management of pharmaceutical information
Other (participation in various meetings, training, etc.)
Elaine Montes
Industrial & Life Science -
Job number: JN -072024-141139 Posted: 2025-06-16
[Ascent] CMC RA
CMC RA8 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Newly started domestic CRO, rapidly expanding in APAC and focusing on smaller to mid sized pharmaceutical companies looking to enter Japan/APAC
- Responsibilities
- Prepare documentation (including for Cartagena Type 1 Applications and CMC Consultations) with team under direction of scientific/ management lead
Interact and manage project communications with clients in bilingual environment
Support interaction with regulatory authorities
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-137826 Posted: 2025-05-01
Senior Manager, Regulatory Manager
Managing two different teams12 - 17 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- We are a foreign pharmaceutical company. Through a merger with an international biopharmaceutical company, we have introduced innovative biotechnology to the Japanese market. Through highly specialized medical information activities, we are enhancing our presence in the Japanese market. Focusing on cancer, cancer immunotherapy, and infertility treatment, we provide innovative healthcare solutions to the people of Japan.
- Responsibilities
- Effective manage regulatory pathway for Life Science (LS) products and services in Japan, cover the areas of biopharma processing, pharm & food materials (APIs, pharmaceutical excipients, food additives), medical devices, IVDs, equipment/instrument, biologics and animal derived materials, etc.
Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of Life Science interests. Safeguard company strategic interests and objectives in arising guidance, standards and regulation.
Monitor and report on changes of relevant regulatory and compliance environment with impact with the Life Science business. Analyze available regulatory and compliance information.
Effective coordination of strategic activities with the company subject matter experts, local regulatory bodies and industry associations. Secure flow of information from/to authorities, industry associations and the Life Science organization.
Training and support to internal stakeholders, external customers and relevant regulatory bodies. Provide relevant training to educate local marketing/sales colleagues about new regulatory trends and developments that drive our value proposition. Definition of processes to implement upcoming regulatory needs and requirements.
Closely work with global/regional regulatory surveillance & advocacy team and regulatory subject matter experts to link the local advocacy activities with global/regional advocacy activities.
Drive, manage and coordinate registration / notification / listing activities in Japan. Ensure the correctness and timeliness of these activities, interim follow-up change management and final outcome. Ensure tracking, maintenance and reporting of registration / notification / listing status.
Provide regulatory guidance in risk assessment, identify regulatory impact to the Life Science and provide regulatory recommendations to mitigate potential risk. Take active role to represent company in delicate or risk potential matters with regulatory agencies, inspectors and trade associations.
Provide regulatory support to marketing, sales and customers via consultation, seminars and training events.
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -042025-186449 Posted: 2025-05-01
【東京】薬事申請業務（医薬品）◇年休122日／1989年に設立されたCROの先駆け企業
一人ひとりに寄り添ったキャリアプラン6.1 - 7.3 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- -
- Responsibilities
- ■業務内容：原薬等登録原簿（MF）登録申請書/外国製造業者認定（AFM）申請書及び添付資料等の作成/レビュー
MF国内管理人業務及びAFM国内代行者業務、海外製造所との英語でのコレポン（主に電子メール）
医薬品・医薬部外品・化粧品等の薬事コンサルティング
PMDA対応業務（対面助言・簡易相談等支援、承認申請後の照会事項回答作成支援等）
医薬品の承認申請書、CTD（資料概要）、添付資料等の作成/レビュー
医薬品製造販売業/製造業/販売業の許可申請書類作成
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-142877 Posted: 2025-05-01
Japan R&D, Medical Writing Senior Specialist or Manager
Medical Writing5.5 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client is a leading global pharmaceutical firm with a presence in about 150 countries and a workforce of around 40,000 employees. The company is dedicated to advancing healthcare through innovative treatments across various therapeutic areas.
In Japan, the firm employs over 2,500 professionals focused on delivering solutions tailored to the specific needs of the local population. By integrating global advancements with local insights, the company collaborates closely with healthcare providers to ensure effective and accessible therapies.
Committed to sustainability and corporate responsibility, the firm strives to improve patient outcomes and enhance the quality of life. Its efforts make significant contributions to both the local and global healthcare landscape. - Responsibilities
- CSRの作成
CTD （臨床部分2.5，2.7等）の作成
CROマネジメント （CSR，CTDを外注する場合）
照会事項回答の作成
対面助言相談資料の作成等
上記業務に関する後進の指導育成
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-142574 Posted: 2025-05-01
Regulatory Strategist
RA8 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- Our client is one of the most well-established European-based international pharmaceutical companies in Japan.
- Responsibilities
- Build a registration strategy for efficient product development in Japan to get fast approval of new projects (new product, new indication, new dose & administration, new formulation, etc.).
Coordinate the relevant functions to prepare the documents which should be submitted to PMDA and/or MHLW such as the documents relevant to PMDA consultation and Orphan Drug Designation.
Support the dossier manager to lead the relevant functions to prepare the required documents for NDA/sNDA submission and answer documents to inquiries during NDA/sNDA review by PMDA, and conduct the following activities.
Ensure other functions to prepare the documents to be submitted to Health Authority on products.
Contribute to the global regulatory activities on projects in charge by inputting regulatory strategy in the global regulatory strategy.
Provide Global Regulatory Team (GRT) with the Japanese legal/regulatory requirements and Japanese development strategies if necessary.Graps the regulatory information such as HA’s movement, legal requirement on NDA/sNDA guidelines, etc
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -042025-186482 Posted: 2025-04-22
薬事申請業務（医薬品）
CMC開発研究のご経験をお持ちの方必見です5.3 - 6.4 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- -
- Responsibilities
- 原薬等登録原簿（MF）登録申請書/ 外国製造業者認定（AFM）申請書及び添付資料等の作成/レビュー
MF国内管理人業務及びAFM国内代行者業務、海外製造所との英語でのコレポン（主に電子メール）
医薬品・医薬部外品・化粧品等の薬事コンサルティング
PMDA対応業務（対面助言・簡易相談等支援、承認申請後の照会事項回答作成支援等）
医薬品の承認申請書、CTD（資料概要）、添付資料等の作成/レビュー
医薬品製造販売業/製造業/販売業の許可申請書類作成
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -032025-185429 Posted: 2025-04-22
薬事業務担当
医療機器規制に関する知識、薬事申請スキルをお持ちの方必見です10 - 11 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- The company is a Japanese optical equipment manufacturer. It engages in the development, manufacturing, and sales of precision measurement equipment. Operating in various fields such as construction, agriculture, and healthcare, it provides surveying equipment and location-based technology. Particularly in the construction industry, it offers automatic control technology for construction machinery and surveying/geospatial information systems to support efficient construction operations. In the agricultural sector, it provides equipment for automatic control of agricultural machinery and devices for precision agriculture, contributing to increased productivity and environmentally conscious farming practices. Furthermore, it develops and provides medical equipment and technology, contributing to the realization of advanced healthcare.
- Responsibilities
- 医療機器申請判断（新製品/設計変更に対する、薬事申請要否判断）
新製品・設計変更計画時の薬事申請戦略立案、実行
薬事申請資料作成、照会対応
法規制情報の収集・管理と、社内対応計画の立案、実行
上記に関連する技術文書、臨床評価関連文書のレビュー
上記に関連する社内外・国内外の関係者(薬事当局含む)との折衝
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -122024-182154 Posted: 2025-04-22
プロジェクトマネジメント（原薬開発）
製薬企業またはCDMOにおけるCMC領域の実務経験を５年以上お持ちの方必見です。7 - 9 million yen Saitama Pharmaceutical Regulatory Affairs
- Company overview
- We are committed to providing high-quality products and delivering appropriate safety information to patients and consumers worldwide. In our pharmaceutical business, we focus on developing anticancer drugs and other medications, offering treatments for cancer, immunology, allergies, and urology. Additionally, in our consumer healthcare business, we cultivate well-loved brands that contribute to the health and well-being of consumers over the long term.
- Responsibilities
- 原薬開発のプロジェクトマネジメント及び治験原薬、中間体、原料の調達関連業務をお任せします。合成及び分析研究員から構成された原薬開発チームのチームビルディング
グローバル又はローカルプロジェクトの原薬開発戦略及び計画の策定、推進
プロジェクトのスケジュール及び予算管理
外部委託先等を活用した治験原薬・中間体・原料の調達関連業務
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -032025-185426 Posted: 2025-04-22
薬事・臨床業務リーダー
医療機器法規制対応または臨床試験に関連したPJのマネジメントスキルをお持ちの方必見です7 - 9 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- The company is a Japanese optical equipment manufacturer. It engages in the development, manufacturing, and sales of precision measurement equipment. Operating in various fields such as construction, agriculture, and healthcare, it provides surveying equipment and location-based technology. Particularly in the construction industry, it offers automatic control technology for construction machinery and surveying/geospatial information systems to support efficient construction operations. In the agricultural sector, it provides equipment for automatic control of agricultural machinery and devices for precision agriculture, contributing to increased productivity and environmentally conscious farming practices. Furthermore, it develops and provides medical equipment and technology, contributing to the realization of advanced healthcare.
- Responsibilities
- 医療機器申請判断（各国薬事申請）
医療機器申請判断（治験必要性判断、臨床評価改定必要性判断）
各国薬事申請関連PJのマネジメント
各国薬事申請書類のレビューと、薬事申請照会対応
臨床試験の計画策定、実行
MDR 臨床評価のレビュー
上記業務のマネジメントもしくはマネジメント補佐
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -032025-185323 Posted: 2025-04-22
薬事部門
薬事および品質部門におけるコンプライアンス業務の実務経験を有する方必見です6.36 - 12.6 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.
- Responsibilities
- ① グローバルSOPおよびWIの管理世界各地の規制に基づいた標準業務手順（SOP）や作業指示書（WI）の策定および遵守状況を監視することで、適切な業務遂行を促すと共に、ギャップ分析を実施し、業務プロセスの最適化を図ります。
②グローバルリスクレジスターの運営GRAにおける規制リスクの特定や追跡を行い、リスク軽減のためのプロセスを実装する活動を支援します。
リスクに関する情報を適切なステークホルダーと共有し、透明性のあるコミュニケーションを促進します。
③ コンプライアンスおよびアクションプランメトリクスの開発会社のアクションプランに沿ったメトリクスを設定し、進捗状況を報告・管理します。GRAの他のサブファンクションとの協力を強化し、コンプライアンス状況の可視化を図ります。
④トレーニングおよび査察準備GRAにおけるトレーニングプログラムを管理し、スタッフが最新のコンプライアンス要件を理解できるようサポートします。GRAが関与する監査や査察の準備に際し、必要なデータや資料の整備を支援します。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -032025-185416 Posted: 2025-03-13
【東京／板橋】【品質保証】薬事業務担当［中国スタート想定］◇担当～エキスパート◇フレックス
中国薬事申請経験、臨床評価業務経験お持ちの方歓迎5 - 9 million yen Tokyo Pharmaceutical Regulatory Affairs
- Company overview
- The company is a Japanese optical equipment manufacturer. It engages in the development, manufacturing, and sales of precision measurement equipment. Operating in various fields such as construction, agriculture, and healthcare, it provides surveying equipment and location-based technology. Particularly in the construction industry, it offers automatic control technology for construction machinery and surveying/geospatial information systems to support efficient construction operations. In the agricultural sector, it provides equipment for automatic control of agricultural machinery and devices for precision agriculture, contributing to increased productivity and environmentally conscious farming practices. Furthermore, it develops and provides medical equipment and technology, contributing to the realization of advanced healthcare.
- Responsibilities
- ■業務詳細：世界各国の医療機器規制対応に関連する下記業務 (担当国は中国を予定するが、それに限定しない)医療機器申請判断（新製品/設計変更に対する、薬事申請要否判断）
新製品・設計変更計画時の薬事申請戦略立案、実行
薬事申請資料作成、照会対応
法規制情報の収集・管理と、社内対応計画の立案、実行
上記に関連する技術文書、臨床評価関連文書のレビュー
上記に関連する社内外・国内外の関係者(薬事当局含む)との折衝
Martin Tsvetkov
Industrial & Life Science
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