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

1. Prepare bill of material (BOM) for new products. Revise BOM for existing products when there are changes 2. Prepare/revise standard operation procedures (SOPs), forms and work instructions (WI) related to SAP BOM. 3. Preparation of change controls \ Process validation documents \ Stability protocols \ Shipping study \ Risk assessment \ Batch master file \ Other associated documents to assist activities including manufacturing\packaging process validation\verification\ optimization and routine commercial production of products made by Lotus site 4. Conduct associated training via training system and internal or external trainings 5. Provide support to any GMP inspection activities 6. Implement any other task assigned by superior

1. 制定/維護/更新使用於研發專案之臨床批及查登批的所有原、物料之規格及化驗方法。 2. 向原料及物料廠商索取相關文件，如：規格與檢驗方法、原料主檔案、技術文件等；審閱3. 廠商提供之技術文件，如有需要，進一步向廠商索取其他文件進行評估，做適當的整理與歸檔。 4. 協助CMC文件準備，提供主成分、賦形劑、包材之檢驗規格予法規部門，使其可進行NDA和ANDA查驗登記的文件整建作業。 5. 審閱B2B差異清單，並準備成本估算、工作計畫，並依據時程制定時間表，並及時協助B2B專案相關的客戶問題的完整回應。 6. 根據B2B需求準備和審核文件，例如檢驗規格、分析方法、標準操作程序等。 7. 按客戶要求準備CMC文件，使其可進行NDA和ANDA查登的文件整建作業。 8. 協助查廠時與實驗室相關之PIC/S GMP文件。 9. 查廠期間支援QA文件調閱與查核。 10. 主導變更管制之撰寫、偏差事件調查、矯正預防措施之評估與執行。定期更新、審閱及維護部門之標準操作程序。 11. 定期更新/採購各主要國家之藥典公定書。 12. 確保所有活動和分析均符合GMP、正確的程序、法規指南以及健康安全法規。

※※※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. Evaluation of submission feasibility for in-licensed products (major) and domestically manufactured products in the APAC region (KR, TW, HK, SG, MY, TH, VN, PH, and ID) 2. Coordination of the due diligence and production of the gap list 3. Evaluation and plan of the design, the budget, and the timeline for the bioequivalence study, the bridging study, and the clinical study in KR and TW 4. Communication with the APAC regulatory teams and partner companies to resolve the submission gap in the target markets 5. Design and consolidation of the regulatory strategy of the key milestone, the submission pathway, the submission timeline, and the launch timeline in the target markets 6. To review the License and Service Agreement 7. To support new submissions in Taiwan 8. To update of the APAC regulations 9. To prepare the consultation materials 10.To provide the justification materials on the non-clinical and clinical studies for the deficiency letter 11. To compile the ACTD format from the CTD format 12. To monitor submission progress on all company's projects 13. To provide improvement plans 14. The other tasks 1. 協調法規相關部門與供應商評價授權產品 2. 評估產品於亞太地區註冊之可行性，準備註冊所需相關技術文件與試驗 3. 在產品開發及送件準備期間提供法規要求的指引，協助其符合國際法規 4. 即時提供註冊用產品主檔案 5. 協助提供法規更新計畫 6. 即時支援產品維護用技術文件 7. 協助擬定合理且經濟可行之註冊計畫 8. 協助執行註冊計畫

1. 具備藥局相關業務經驗 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 *本職務實際業務責任區需依公司分配，以基隆/雙北為主，需出差。

1. Support and facilitate business user's requirement to seamlessly running at corporate SAP system (MM or PP modules) 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.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