1. Utilizing strategic sourcing process to identify, negotiate and implement packaging materials, indirect materials, procurement initiatives to drive cost savings. 2. Align with sourcing team to provide local business requirements and market information to support effective collaborative regional strategy creation and execution 3. Partnering with RD / RA/ NPL, and other Functional groups (Executives, Quality, R&D, Regulatory Affairs, Finance, Legal, Engineering….) in discovery, contract negotiation, optimizing economic value, on-time delivery of product & services, cost management & reduction, supplier & partner risk mitigation, and scope of work development. 4. Develop and implement forward thinking procurement strategies to both optimize spending and minimize risk. 5. Creation of effective preferred supplier program and instillation of organizational discipline on onboarding new vendors. 6. Development of KPIs for strategic sourcing with cyclical delivery which drives continuous improvement. 7. The primary work location for this position can be based in Taipei or Taichung offices, in addition to the Nantou site. The incumbent is required to work on-site at the Nantou facility at least 1 to 2 days per month, subject to business needs.

Job Summary: This position is based at Lotus Taipei office and involves working closely with the local RA teams to manage the registration for in-licensing products. The role is accountable for RA experiences in new submissions and life-cycle management across both Asia and Southeast Asia. English communicative skills in spoken and writing clearly, concisely, and effectively are essential. This role offers exposure to an international RA environment and facilitates the development of expertise in regulatory affairs and project management. 1. Initiate, coordinate and supervise the registration of medicinal products from the company portfolio through national procedures in the APAC region. 2. Coordinating the evaluation of possible regulatory strategies and provide support for preliminary reviews of new projects. 3. Providing support for samples preparation and dispatch, when necessary. 4. Ensuring all the additional processes relating national submissions (pre-reviews, DMF, PMF and GMP accreditation etc.) are submitted on time and those submissions/approval processes do not delay drug registration. 5. Communicating with third parties in order to expedite submissions and ensure regulatory compliance. 6. Ensuring all responses to authorities’ requests are correct, complete and timely submitted, including the responses to LoDs for the allocated projects as well as the ones related to PI for all the ongoing procedures. 7. Ensuring that accurate and complete information is timely provided to other departments/third parties and inform the relevant functions on the status and progress of the assigned projects in order to meet the set objectives, identify potential problems or delays, and possible solutions, as they occur. 8. Controlling costs and ensure proper internal evaluation and approval for each cost before it is being generated. 9. Providing support for documents and samples preparation for tenders and legal activities related to patents. 10. Coordinating the arrangements for inspections requested by the local authorities. 11. Maintaining the current knowledge of applicable legislation within the responsibility area in line with the most up-to-date provisions. 12. Ensuring that the internal regulatory database applicable trackers and SharePoint locations are kept up-to-date.

1.依據需求計畫部門提供的銷售預測，排定生產計劃，供製造部排定排程。 2.依據需求計畫部門提供銷售預測排定生產年度計劃，依ERP建議原物料需求建立請購計畫。 3.依據生產計畫建立工單。 4.依據採購計畫建立請購單/依據研發原物料需求建立請購單 5.依據製造排程協調原物料狀況並掌握進度。 6.固定召開生產排程會議 7.製作週報及月報表供主管參考 8.跨部門工作之溝通與協調，協助與配合完成上級交辦之工作

1. Plan and execute internal audits and special projects to evaluate the risks and the effectiveness of related controls. 2. Prepare reports for each engagement and communicate audit observations with corporate, regional, and local management. Apply problem solving skills to issues and provide practical and constructive recommendations. 3. Develop credibility and trust with operating functions to value-add internal controls and management. 4. Monitor changes in Company policies and procedures to align with the applicable Regulations, Standards, and industry practices.

1. Provide leadership and manage the work activities of direct reports in the area of application development for Commercial-off-the-Shelf applications that includes new solutions and enhancement of existing applications 2. Collaborate with business and key IT stakeholders to plan, prioritize, and schedule applications development and enhancement requests, while providing direction and guidance to the applications development staff 3. Accountable for availability and performance of applications portfolio, including ownership of incidents and release management 4. Drives stakeholder satisfaction by delivering quality applications and support with controlled and planned change management and communicate project status to various levels of management 5. Partner with leaders of other disciplines to ensure proposed solutions align with information, technology, infrastructure, business and security architectures 6. Provide oversight in standards adherence through reviews of project work including detailed technical specifications and application code 7. Proven experience in managing relationships with vendors/consultants, IT teams and internal stakeholders 8. A passion for all things tech and a drive to experiment with new technologies to see where they can benefit the business and staying hands-on technical as well as wearing that team management hat

1. Plan and execute product strategy and launch plan including market analysis, positioning, and pricing 2. Collaborate with regulatory, supply, market access, medical, and sales teams for effective execution 3. Develop and implement marketing programs/activities including CME, KOL engagement, digital promotion, and PSP 4. Manage budget and ensure optimal resource allocation 5. Build and maintain strong relationships with healthcare professionals, institutional stakeholders, and relevant external partners to support product acceptance 6. Provide sales tools and training to support listing and prescription growth. 7. Monitor performance, forecast demand, and propose improvement actions based on KPIs 8. Prior CNS experience is highly preferred 9. Experience in new product launch is a plus

1. 執行銷銷售策略，傳遞企業形象與產品價值，達成業績目標。 2. 執行客戶分級與區域管理，並與主管共同設定客戶拜訪計畫並落實。 3. 規劃並執行院內小型行銷活動，並偕同行銷部門執行大型行銷活動。 4. 完成區域內各醫院進藥資訊及取得進藥資格，並進行保藥作業。 5. 收集市場資訊、執行緊急事件處理並回饋內部。 **工作地點依公司指派 (以TW南部地區為主)

Good at one of the below HR functions: 1. Talent Acquisition: - Facilitate to consolidate headcount plans to support the company's operations - Plan and recruit desired manpower within appropriate timeline. - Manage recruitment process structurally and consistently. 2. Learning & Development: - Plan and structure learning and development framework in order to deploy learning activities in the organization with clear approach and direction. - Design / Deliver / Conduct Trainings with quality of work. 3. Compensation & Benefits: - Ensure the correctness of C&B related data (including payroll) and timely. - Ensure company activities in line with labor related regulations - Manage Performance Management cycle properly and deliver relevant training / communication to navigate positive culture in the organization.

1. To meet the productivity including the cycle time, wastage, outputs, yields, and quality objectives for all the production lines in the function section. And report the output daily and weekly basis. 滿足生產率，包括週期時間、浪費、產量、產量和功能部分所有生產線的質量目標。並每天和每周報告產量。 2. To ensure the team members are performing the production and GMP activities aligning with the procedure. And the SOPs are followed robustly. 確保團隊成員執行符合程序的生產和GMP活動。並嚴格遵守SOP。 3. Provide initial troubleshooting for program or equipment failures. And report the issues to the superiors. 提供程式或設備故障時的初步排除。並將問題報告給上級。 4. To perform daily Gemba on the production and site area. 每天在生產和現場區域執行Gemba。 5. To ensure the line clearance and line opening verification as per SOPs are robust. 確保按照SOP進行生產線間隙和開線驗證是穩健的。 6. To provide training to the team members about the operational and cleaning methodology of pieces of machinery/premises, material requisition, area clearance, process reconciliation procedures, in-process sampling checking and testing, environmental monitoring, cGMP, etc. in line with Standard Operating Procedures and Batch Records. Periodically provide training to the operators for the GMP awareness and the SOPs. And periodically verify the training effectiveness of the team members. 根據標準操作程式和批次記錄，為團隊成員提供有關機器/場所的操作和清潔方法、材料申請、區域清理、過程核對程式、過程中抽樣檢查和測試、環境監測、cGMP等的培訓。定期對操作人員進行GMP意識和SOP培訓。並定期驗證團隊成員的培訓效果。 7. Stop production and inform the superior of any abnormality or deviation that can impact the identity, quality, purity, and efficacy of the product. Maintain the cGMP and quality standards for the environment, equipment, and process within the responsible function section. 當有任何可能影響產品特性、品質、純度和功效的異常或偏差時停止生產並通知上級。在負責職能部門內維護環境、設備和流程的cGMP和質量標準。 8. To participate in the investigation of the deviation, customer complaint, Gemba, or inspection finding and be involved in the proposal and performing of the corrective/preventive action. 參與偏差、客戶投訴、Gemba或檢查結果的調查，並參與矯正/預防措施的提議和執行。。 9. To implement and practice good housekeeping and 5S in the respective section. 在負責的生產線中實施和練習良好的內務管理和5S。 10. Monitor and ensure shop floor staff adheres to all safety procedures. 確保現場工作人員遵守所有安全程序。 11. To conduct the assigned CAPA and CCR action to increase the quality and productivity of the production. 執行被指派的CAPA和CCR任務來提升生產品質與產能。 12. Perform any other duties as assigned to you by your superior. 履行上司分配給您的其他職責。 13. Responsible for daily on-site monitoring for most of the working time (≧80%), and responsible for personnel education, training and clerical related work for the remaining working time. 大部分工作時間負責每日現場的監控(≧80%)，其餘工作時間負責人員教育訓練與文書相關工作。

※※※擴大徵才，工廠提升計畫完工，製藥產線擴大生產規模※※※ 依廠內標準作業程序和現行GMP規範，按排程和製造批次執行產品製造，工作內容包含： 1. 負責執行產品生產相關工作 2. 負責執行產品之製造 3. 負責生產進度及狀況，確實填寫批次記錄及相關表單 4. 執行設備及工作環境清潔及維護 5. 製程設備操作 (混和、打錠、造粒、充填、熔膠、壓丸、定型乾燥等)及相關GMP文件記錄填寫 6. 包裝機台操作(片裝、瓶裝、盒裝、裝箱等)及相關GMP文件記錄紀錄填寫 7. 其他主管交辦事項 加入我們的美時製藥產線團隊，讓您的技術熱情得到最大發揮！ 您將獲得製藥工藝和高品質生產技術的完善訓練及升遷制度，立即加入我們，美時是您製藥成就發展之路的唯一選擇！