Jobs list of Pharmaceutical

新規事業企画：ヘルスケアプラットフォーム事業

医療業界経験をお持ちの方必見です

7 - 10 million yen Tokyo Pharmaceutical Marketing

Company overview: Our client is a prime SI that provides comprehensive IT solutions.
Responsibilities: 新規事業企画の立案、新たなビジネスモデルの構築
ステージゲートプロセスを理解した事業開発・推進（ニーズ検証、MVP開発、PoC推進など）
投資計画の作成/実行、サービスのローンチ
オープンイノベーションやアライアンス形成、推進

製薬メーカーでの内勤サポート <オフィスメディカル>

豊富なキャリアパス／研修教育環境充実

6.5 - 9.5 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.
Responsibilities: <業務内容＞
オフィスメディカルは、メディカルアフェアーズ機能の内勤職として、医療現場における『アンメットメディカルニーズを把握』し、把握したニーズを充足することにより医療上の価値を最適化するための『メディカルプラン』に基づいて『エビデンスを創出』すると共に、創出したエビデンスを含む医学・科学的情報を『適切に発信、提供』を行う役割を担っていただきます。
業務内容は役割により多岐に渡りますが、代表的な業務内容を下記に記載いたします。
オフィスメディカルには「メディカルアドバイザー」「サイエンスコミュニケーションズ」「メディカルインフォメーション」と呼ばれる職種が該当します。

メディカルプランの作成
アドバイザリーボードの立案/実行
メディカルイベントの企画/実施
資材作成やスライドレビュー業務
パブリケーション戦略、メディカルエデュケーション企画実施
医療従事者や社内 MR、患者様からの取扱製品に関する問い合わせ対応
メディカルインフォメーション（2 次対応）
最新医学情報の収集と社内関連部署への提供
グローバル関連部署との折衝やコミュニケーション
関連業務のサポート全般（書類等の作成、確認、保管、発送業務等）

■研修体制：
同社の豊富な実績やデータ、ネットワークをもとにヘルスケアの基礎から、営業・マーケティング、臨床、データ・テクノロジー、マネジメント・リーダーシップ、経営など、これからの医療・ヘルスケアの担い手に求められる多様なプログラムが体系化されています。MSL専門プログラムも用意されており、基礎から応用、実践まで対応可能です。

[Tokyo] Medical Science Liaison in Diabetes

Rich Pipeline and Expanding

5 - 12 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: Our client is a global healthcare company.
Responsibilities: Identifies, lists and communicates with KOLs and HCPs in the practice setting (e.g., academic centres, investigators, IISs research site) to update their understanding of relevant data in each context related to products, as well as to build and maintain relationships to facilitate scientific exchange on topics of relevance to company.
Assists in identifying, engaging, and maintaining relations with KOLs and HCPs to establish and/or further the knowledge of products and their appropriate use; when necessary, assist in resolving issues pertaining to that use.
Assists in identifying and responding to inquiries from KOLs and HCPs; assisting with identifying those individuals with novel research concepts, clinical experience and expertise, within identified therapeutic areas of interest.
Gathers Medical insights regarding company and competitors’ products from KOLs and HCPs to help inform company decision-making bodies and update the Medical and/or Marketing Strategies if necessary.
Participates in assigned medical and scientific meetings to maintain awareness of current issues and new data pertaining to company and competitors’ products and to support medical booth in answering physicians’ scientific questions.
Identifies and develops strong and convincing speakers for our marketed products aligned with the Medical Strategy.
Assists regional Medical Representatives (MRs) in handling scientific and clinical questions for company marketed products from KOLs and HCPs.
Support the on boarding of new MSLs where required.
Support clinical trials by driving scientific discussion at site selection and site initiation visits where required.
Support scientific dialogue with investigators at prioritized/requested sites and patient recruitment and retention of subjects where required.
Participates in a series of internal medical/scientific trainings and regular scientific assessments to maintain general scientific knowledge and awareness of new data pertaining to company and competitors’ products.
Complies with all guidelines, policies, legal, regulatory, and compliance requirements.

QM部品質システムグループ

Global Company

5 - 8 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

Company overview: Our client is a leading global pharmaceutical company committed to enhancing health and quality of life. With a significant presence in Japan, the firm operates from its Tokyo branch with over 1,500 dedicated employees.

Globally, the company employs over 58,000 people and has a footprint in more than 130 countries. The focus is on research and development in key therapeutic areas, including respiratory, cardiovascular, and oncology, driving innovation and excellence across its extensive pipeline of therapies.
Responsibilities: 1. 製品製造所及び原薬製造所の管理
製造業者等との取り決めを作成する
製造所の製造管理及び品質管理が適正に行われている事を定期的に確認する (GMP査察の実施)
製品に関する変更管理及び逸脱管理を確実に行う
薬機法で定義された事項について品質保証責任者へ報告す
品質に関する問題の解決にあたり、製造所または他の部門と協働する

2. HP Supply Japan における品質マネジメントシステム (QMS) の構築・維持
HP Supply Japan における QMS を構築・管理する
HP Supply Japan の他部門と協力し，local SOP と社内基準の調和を図る (OCP/OCS 等の落とし込み)
製品に関する品質標準書の作成を行う
GQP省令で定められた品質管理業務手順書の作成を行う
記録及び文書を適正に維持管理する
製品の品質照査を実施する
HP Supply Japan における GDP を維持・管理する
KPI等の Quality に関する情報をタイムリーに集計し、報告する

3. 製品を市場へ出荷する
製造所における製造管理及び品質管理の結果を適正に評価すると共に，市場への出荷を適正かつ円滑に行う

4. 品質に関する情報、品質不良及び回収に関する業務を行う
市場からの品質苦情について調査・分析を行い、必要に応じて製造所に改善を指示する
入手した品質情報，品質不良について，原因調査及びその評価を行い，改善策を策定する
製品回収において，必要な対応を迅速に調整・実施する

5. Corporate 及び HP Supply Japan プロジェクトへの貢献
corporate主導のプロジェクトに関する情報を収集する
関連する corporate主導のプロジェクトや会議に積極的に参加・貢献する
HP Supply Japan が進めるプロジェクトへ貢献する

6. 東日本及び西日本 DC での GMP 品質部門として機能する
DC GMP を維持・管理する Establish and maintain DC GMP.
DC での輸入製品の GMP 出荷業務を行う

【静岡／鎌倉】非臨床DMPKリーダー

創薬の非臨床薬物動態研究での実務経験3年以上お持ちの方必見です。

6 - 9 million yen Kanagawa Pharmaceutical Research & Development

Company overview: We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
Responsibilities: 創薬テーマのDMPK機能リーダーとして、担当テーマのDMPK及び生体試料分析の課題を関連部署と協働して解決し推進する。
技術課題解決のための新技術確立、ならびにアカデミアや海外関連会社との共同研究を通じた外部からの技術導入の推進役を担う。

Manager, Bio-Statistician

Global Company

10 - 13 million yen Tokyo Pharmaceutical Data Management / Biostatistics

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization projects.
Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports (topline reports, clinical study reports, etc.), including clinical trial/PMS results, support for publication activities, scientific presentations, and support to responses to queries from regulatory authority.
Be accountable for study/PMS level and submission level statistical deliverables on assigned projects.
Develop effective collaborations with others within clinical teams, partner lines, external regulatory, industry, professional and academic organizations.
Ensure that all study/PMS and project level statistical activities are conducted in compliance with relevant regulatory requirements and standards.
Be up-to-date on SOP training and compliance with all SOPs as required based on the assigned curriculum.
Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, data managers, clinical programming colleagues – for assigned studies/PMS and regulatory submissions.
Ensure timeliness and quality of statistical deliverables according to project plans for assigned projects.
Comply with all statistics and quality processes and data standards that are applicable to statistical outputs, and support processes that require statistical input.
Communicate and collaborate with global statisticians on assigned projects.
Provide a strong statistical presence in regulatory and professional circles.
Participate in research on statistical methodology and its applications to clinical trials/PMS.

Associate Director, Quality Assurance

Quality Assurance

6 - 10 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

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: The Commercial Quality Lead - Japan has the overall Quality oversight & responsibility to ensure Quality and Regulatory compliance of all Commercialized Products, Japan LOC , Consumer related Distribution Centers and Warehouses within Japan base business, ensuring all applicable regulations as well as Enterprise Quality Policy Standards and procedures . The incumbent is also responsible for end-to-end Franchise Quality under Marketing Authorization and Quality Management System (QMS).
This position is also responsible for Quality Assurance Supervisor (QP) who is accountable for quality assurance of Marketing Authorization products and reports to General Marketing Supervisor (SoSeki) in good collaboration with Safety Management Supervisor (AnSeki).

臨床開発業務（クリニカルプログラムマネージャー）

グローバル開発戦略の策定に携わって頂けるポジションです！

8 - 13 million yen Tokyo Pharmaceutical Clinical Development

Company overview: We are a leading pharmaceutical company in Japan, offering a wide range of products in the medical field. Our product lineup includes various pharmaceuticals to support patient health, and we are also dedicated to research and development. We strive to develop new treatment methods and medications to contribute to the treatment and prevention of diseases. Additionally, we operate globally, providing our products to patients worldwide. We uphold high standards of quality and safety, contributing to the advancement of healthcare and the well-being of patients.
Responsibilities: 以下のいずれかの業務にあたっていただきます。
①クリニカルプログラムマネージャー
臨床試験（治験）の実施と日本・アジアでの承認申請を行う実務責任者。海外チームと連携してグローバル開発戦略を作成し、社外オピニオンリーダー、研究部門、技術部門、グローバルマーケティング部門等と連携しながら臨床開発計画の立案、臨床試験計画立案・実施、PMDA・アジア各当局に対する相談・承認申請の中心的役割を担う。また、導入候補品の評価なども行う。

②スタディーマネージャー
臨床試験（治験）の実施と日本・アジアでの承認申請を行う。特に臨床試験の実施に際してチームメンバー（モニター）の指導・管理、CROの管理、社外オピニオンリーダーとのコンタクトを行う。またクリニカルプログラムマネージャーと共同し、海外チーム、研究部門、技術部門、マーケティング部門等とコンタクトをしながらグローバル開発戦略の作成、臨床開発計画の立案、臨床試験計画立案・実施、PMDA・アジア各当局に対する相談・承認申請を行う。

③プロジェクトマネージャー
グローバルプロジェクトリーダーと連携し、グローバル開発戦略・計画を策定する。また、国内・海外の複数部門のメンバーで構成されるグローバルプロジェクトチームの活動をマネジメント（タイムライン管理、予算管理、リスク管理、問題解決等）する。

Manager (Principal Statistician), Statistical Modeling & Methodology, Statistics

統計解析の経験ある方必見です

10 - 15 million yen Tokyo Pharmaceutical Data Management / Biostatistics

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: Accountability:
Provide statistical expertise in clinical development programs, development strategy, study design, data analysis and interpretation of results for clinical trials;
Contribute to develop clinical development programs, development strategy and study design, in terms of statistical viewpoint, based on advanced TA/DA knowledge.
Support broad implementation of innovative statistical approaches across the development portfolio.
Support development and implementation of innovative approaches, participating in their hands‐on implementation through direct interactions with statisticians. This involves, but is not limited to, identifying appropriate designs and methods, decision rules (e.g., Go/No Go); planning, running, and summarizing simulation studies to evaluate the operating characteristics of alternative designs and methods under a range of scenarios; and participating in the implementation of the selected approaches by engaging in protocol and SAP write‐up.
Participate in training and presentations on innovative approaches across the R&D organization (including statisticians, pharmacometricians, clinicians, and other stakeholder groups) to ensure awareness and adequate knowledge about these methods. Keep up‐to‐date knowledge of designs and analysis methods for clinical trials, including adaptive designs, model‐based methods, etc.
Collaborate with external consultants to provide support in the development and implementation of innovative methods and designs.
May engage in external collaborations within professional associations, participating in working groups, program committees, organizing sessions and presenting at scientific meetings, and publishing in peer reviewed journals
Identify opportunities for innovation; interact directly with statisticians and other “Quantitative Sciences” scientists (including global) for early identification of opportunities for innovative approaches.
Contribute people development through coaching and advices with line managers in Biostatistics dept.

Decision Making:

Proposal statistical modeling approach to meet requirement and/or to solve issues for clinical development program.

Influence:

Facilitate strategic & data‐oriented (quantitative) discussion by utilizing statistical thinking such as modeling & simulation approach
Provide statistical expertise to develop persuasive/logical data interpretation for regulatory approvals in timely manner.
Implement “state‐of‐the‐art” statistical strategies and advanced methodology
Lead the implementation of modeling & simulation approaches for development programs in Japan R&D through cross functional collaboration not only in Japan R&D but also global QS.

Interface:

Internal; J‐CoT (Japan Compound Team), QS‐J Matrix team, Group managers in Biostatistics dept, Statisticians including Statistical Modeling & Methodology (SMM) in SDS of global QS for projects assigned
External; PMDA, Academia related to TA/DA assigned, Professional societies

開発薬事責任者

ニッチ業界で成長を続ける成長企業

8 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs

Company overview: Our client is providing drug development service.
Responsibilities: 部門の管理、人財マネジメント
営業活動
部門の予算管理
医薬品・医療機器関連の治験相談
メディカルライティング業務管理
医薬品・医療機器に関する法規制への対応業務
各国申請代理人との連絡・調整
当該国薬事規制等の調査
アジア地域における医薬品・医療機器開発戦略コンサルティング（各種試験成績・資料の評価、医薬品・医療機器承認申請に係る当局対応、申請届出等）

【鎌倉】タンパク質科学・分子間相互作用解析分野の専門性を有する研究員

精製系の構築を含む業務経験者必見です!

6 - 9 million yen Kanagawa Pharmaceutical Research & Development

Company overview: We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
Responsibilities: 医薬品の研究、開発、製造、販売および輸出入行う当社において、タンパク質科学や分子間相互作用解析の専門性を通じた創薬および技術プロジェクトの推進をお任せいたします。

Account Manager

Sales

10 - 14 million yen Tokyo Pharmaceutical Sales / MR

Company overview: Our client is a life sciences and materials science company.
Responsibilities: Manage and grow existing accounts
Identify, qualify, and develop new business
Manage support and solutions teams within accounts and provide critical feedback to aid in product development
Collaborate with Marketing Director to develop territory-specific advertising strategies
Produce timely and accurate business reports and revenue forecasts
Represent company at conferences
Report to the Tokyo office when not traveling for company business

[Kyowa Kirin] 臨床試験計画やCROマネジメント業務

製薬企業でのモニター経験がある方必見です!

6 - 9 million yen Tokyo Pharmaceutical Clinical Development

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: 臨床試験計画の立案・実行・評価
CROマネジメント
国際共同試験（欧米亜）の実行又は支援
機構相談資料や申請資料の作成、当局の審査対応
開発化合物の導入導出評価

CMC Project Leader

Global Company

6 - 8 million yen Tokyo Pharmaceutical Research & Development

Company overview: We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
Responsibilities: CMC開発部門におけるプロジェクトリーダー（開発プロジェクトのCMC開発戦略・計画の策定とCMC関連部門の統括）
グローバル治験薬・商用生産体制の構築および治験薬・製品供給計画の策定と実行

Contracts Manager （グローバルメガファーマプロジェクト）

臨床試験立ち上げ業務のご経験が活かせます！

8 - 15 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Our client is the Japanese subsidiary of a European CRO with over 100 offices and tens of thousands of employees worldwide.
We have a strong business foundation providing global drug development services and a vision to be a “Global Healthcare Intelligence Partner”. We aim to provide advanced drug development operations by combining our experience in drug development with technology that enables 100% virtual clinical trials.

As a partner to pharmaceutical manufacturers and bio-venture companies, we provide a wide range of support from clinical trials to regulatory filings and post-marketing activities. We can also provide a comprehensive range of services including regulatory affairs, pharmacovigilance, and medical writing.
We have a culture where employees work healthy and enjoy challenges, and have been awarded “World\'s Best Company” multiple times by Forbes, an American economic magazine.
Responsibilities: リーガルの観点から臨床試験の施設契約、機密保持契約の内容が問題ないかレビュー、フィードバックをお任せいたします。
またCRAやContracts Associate対して、交渉ガイドライン、施設契約に関するトレーニングを実施いただきます。
臨床試験を実施するCROとの施設契約に関するレビュー、テンプレート内容の交渉
ガイドライン、日本の相場、適切なSOWに基づく医療機関向け治験費用の分析、および社内承認プロセスにおけるリード
Global CAチーム、Clinical Operationsチームとの連携および協働し、法的なリスクの評価
契約における修正条項やその可能性に関する見立て、および分析業務
契約締結、費用交渉に関するリードタイムの短縮化、効率的なオペレーションの検討

薬事戦略立案

米国の医薬品薬事の実務経験をお持ちの方必見です

5 - 10 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: Our client is an infusion solution manufacturer.
Responsibilities: （1）米国の医療機器の開発から承認（承認変更維持管理を含む）に係る薬事全般業務・薬事戦略立案、FDA相談、FDA申請／承認、医療保険対応など（2）米国の医療機器の薬事制度等の情報収集、教育 ※以下の薬事業務を行う場合もある。（3）米国の医薬品の開発から承認（承認変更維持管理）に係る薬事全般業務（4）日本の医薬品、医療機器等の開発から承認までに係る薬事全般業務薬事戦略立案
当局相談（相談提案、相談資料のレビュー、相談申込、相談対応）
承認申請業務（申請資料のレビュー、申請作業、照会事項対応）
保険収載

MSL

アカデミア出身者歓迎です!

6.5 - 9.5 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.
Responsibilities: KOL を訪問し、アンメット・メディカル・ニーズやメディカル・インサイトの収集・主催、共催の講演会企画の立案、実行ならびに他部門の支援
医療従事者からの非臨床、臨床研究等の相談対応
Data generation plan の策定と戦略達成に必要なデータギャップの特定・パブリケーションプランの作成

製造・品質管理担当者※腸内細菌叢移植の医薬品開発

品質管理実務の経験者必見です!

5 - 7.5 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

Company overview: 同社は、創薬・医療事業を展開しています。
Responsibilities: 腸内細菌叢溶液の製造・品質管理および微生物実験
製造工程の改善検討
ドキュメント類の作成・管理（製造記録、SOPや作業マニュアル、その他製造に必要な書類）
在庫管理と出荷業務
ラボの管理、メンテナンス等・学内医師、臨床研究に関連するメンバーとのコミュニケーション
FMT製剤のサプライチェーン構築のサポート ※すべてを一人で行なう訳ではありません。現社員と協力しながら業務にあたります。 ※FMT：Fecal Microbiota Transplantation（腸内細菌叢移植）

薬事部長

10 - 16 million yen Tokyo Pharmaceutical Regulatory Affairs

Company overview: 新薬の製品化を目指した研究開発、および販売を手掛けています。
Responsibilities: 主担当業務:
開発薬事業務：新薬の開発戦略構築および実行
薬制薬事業務：第１種医薬品製造販売業メンテナンス業務（更新、変更等）
補助業務:
開発薬事業務対面助言
治験届（計画届、変更届、終了届）
承認申請（新規申請、一変申請、GMP 適合性調査申請、軽微変更）
薬価収載等

薬制薬事担者

製薬、医療機器業界における薬制・薬事業務の経験が活かせます。

7 - 12 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
Responsibilities: 許可等業者の法令遵守体制の維持・管理（手順書作成・運用、会議体事務局、GQP/GVP部門との連携等）
国内および海外子会社における製品リスク（回収、偽造医薬品等）への対応
医薬品（再生医療等製品等新規モダリティ含む）及び医療機器の開発・上市に向けた薬事規制に関連する調査、社内連携のリード
社内における薬機法等の薬事規制に関する疑義照会対応業務
海外での医薬品販売承認維持のための薬制業務及びプロジェクトマネジメント業務
国内外の規制当局との授受文書の管理業務
国内及び海外当局等から発出される各種薬事規制の収集・分析・社内への適用推進業務
GMP/QMS/GCTP適合性調査（承認前調査/定期調査）、外国製造業者認定の維持・管理業務
製造委託先への製造・試験法に関する調査等（承認書と製造実態の整合性に係る年次点検、日局改正対応状況の確認等）

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