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. 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

This is a HR COE role. The right candidate should possess at least one of the below expertise. 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. Talent Management: - Design and Facilitate Talent Management process to strengthen the succession pipeline in the organization. Performance Management: - Manage Performance Management cycle properly and deliver relevant training / communication to navigate positive culture in the organization.

※※※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！

1. 具備診所、藥局通路相關業務經驗 2. 市場資訊收集分析、反對意見處理 3. 新開戶開發 4. 客戶分級及區域管理 5. 舉辦Seminar , RTD 6. 推廣及開發OTC指示用藥及處方藥物 **本職務依公司指派之業務責任區(彰化地區為主)

1. Support and facilitate business user's requirement to seamlessly running at corporate SAP system in the landscape via analyzing, designing, and developing. 2. Work closely with the team (other SAP developers, infrastructure & system teammates) to understand business needs and deliver features in good quality at timely manner. 3. Be capable of creating and assessing software architecture/designs with multiple stakeholders. 4. Manage overall change request and/or incident backlog for the owned topics and ensure the high quality of corrections and notes for the owned topic areas and of stable assist packages with no regressions. 5. Exhibit learning agility by quickly upskilling on new tasks and concepts. 6. Assist our business users during product deployment, critical operations, and system rollout via standard infrastructure, creating maintenance notes and documentation.

1. To establish training curricula in accordance with requirement of manufacturing activities, including manufacturing technology, GMP concepts and other working guidelines. 依照製造活動之需求建立訓練課程，包含製造技術、GMP概念與相關工作規範。 2. To establish wide variety of training materials, including SOPs, training slide deck, training video, testing questions and training checking list. 建立各種類型之訓練教材，包含SOP、訓練簡報、訓練影片、課程考題與訓練檢核表。 3. To optimize the current training materials, including revision of SOP, updating of slide deck and editing of training video. 針對現有的訓練教材進行優化，包含SOP改版、簡報更新與訓練影片製作。 4. To conduct effective induction and orientation sessions. 執行有效的新進人員培訓課程。 5. To conduct training activities in accordance with the training program, including newcomer training, SOP training, on-the-job training (OJT), and training activities related to GMP production. 依照訓練計畫執行訓練活動，包含新人訓練、SOP訓練、OJT與GMP生產相關之訓練活動。 6. Compile training document records and save them to training management system and assist in maintaining the training curricula in the training system. 彙整訓練文件紀錄保存至訓練管理系統並且協助維護訓練系統之訓練課程內容。 7. Other works assigned by manager. 其它主管交辦事項。

1.開發調整分析方法(HPLC, GC, IC...)，協助產品製程開發，分析方法之確校 2.執行實驗室設備3Q 3.研擬審查藥典相關產品規格及分析測試，建立藥典規格 4.操作化學分析儀器進行分析，協助產品放行

1. To optimize and streamline operational processes to ensure efficiency, compliance, and continuous improvement in various aspects of pharmaceutical operations. 2. Facilitate root cause analysis from operational perspective and lead problem-solving activities to solve critical quality problems. 3. Foster a culture of continuous improvement within the organization, encouraging employees to contribute ideas for enhancing processes and systems. Implement and manage continuous improvement programs to drive innovation and efficiency in operations. 4. Identify areas for improvement in manufacturing, supply chain, and other operational processes to enhance efficiency and reduce costs. 5. Apply change management methods (lean six sigma, 5S, DMAIC, etc.) to ensure effective execution of process and quality improvement initiatives. 6. Set clear expectations, objectives, assignments, and timing of individual and team deliverables. 7. Develop project plans and be organized to facilitate successful project completions in time, in budget and in quality. 8. Regularly tracks, maintains, and updates the project’s progress and status. To issue escalation to a supervisor in time and collect the feedback for facilitating problem-solving. 9. Perform other related duties as assigned.