藥研開發博士級研究員(天然物分析)

1. Organize regulatory information and track and control submissions, review and advise on submission strategy for compliance with regulatory filings.  

2. Evaluate new proposed change from operation team and assessment impact and requirement on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues and RA team. 

3. Ability to provide clear direction and guidance to RA teams and others. To organize, prioritize, and deliver tasks and projects, with a sense of urgency. Ability to organize team works in timely manner with accuracy. 

4. Represent Regulatory Affairs on project teams to ensure all regulatory requirements are met throughout the product lifecycle.  

5. Regular update RA status in order to align with business objectives, deliver outstanding launches.  

6. Keep closer communication with marketing team and related department proactively to get correct and immediate updates of our products. Need to ensure the variation not disturb the inventory.  

7. Effective in working with multifunctional team and to fix complex matrices. Strong communication, interpersonal, organizational skills and problem solving skills.  

8. Ability to provide clear direction and guidance to RA teams and others. To organize, prioritize, and deliver tasks and projects, with a sense of urgency. Ability to organize team works in timely manner with accuracy. 

9. Relocated in Nantou Operation Center for training for above 6months to a year.

1. 學名藥開發檢驗工作與安定性試驗。 

2. 學名藥分析方法開發與執行方法確效。 

3. 執行原料藥評估、篩選與制定規格。 

4. 配合學名藥處方篩選過程，執行各階段之檢驗分析。 

5. 制訂撰寫、分析研發相關文件與技術文件。 

※依學經歷薪資可再議。

1. Prepare and Submit Regulatory Documentation: Compile, review, and submit high-quality regulatory applications, such as Investigational New Drug (IND) applications, New Drug Applications (NDA), Abbreviated New Drug Application (ANDA), and Marketing Authorization Applications (MAA), to regulatory authorities. 

2. Liaise with Regulatory Authorities: Act as the primary point of contact with regulatory agencies, responding to inquiries, providing additional data, negotiating requirements, and facilitating timely approvals or resolutions. 

3. Monitor and Interpret Regulatory Changes: Continuously track updates in pharmaceutical regulations, policies, and industry trends, interpreting their impact and advising internal stakeholders (e.g., R&D, legal, and marketing teams) on necessary adjustments. 

4. Ensure Product Compliance: Review and approve product labeling, packaging, advertising, and promotional materials to ensure alignment with regulatory requirements, including safety, efficacy, and legal standards. 

5. Manage Regulatory Submissions Timeline: Oversee the preparation and submission process to meet deadlines, ensuring all documentation is accurate, complete, and submitted in accordance with agency specifications. 

6. Maintain Regulatory Records: Organize, update, and archive regulatory documentation, correspondence, and approvals in a systematic manner to support audits, inspections, and future submissions. 

7. Conduct Regulatory Risk Assessments: Identify potential regulatory risks or roadblocks in product development or marketing, proposing mitigation strategies to ensure compliance and project success. 

8. Handle Post-Marketing Changes: Prepare and submit regulatory applications for post-marketing changes, such as updates to manufacturing processes, labeling revisions, or formulation changes, ensuring timely approval and compliance with regulatory standards.

1.產品製程平台熟習 。 

2.各項產品研究開發計畫(製程設計與配發開發)。  

3.小量試製.製程優化。 

4.協助研發技術移轉業務。 

5.其他主管交辦事項。 

＊視學經歷條件,薪資可議,歡迎優秀人才加入~

1. 癌幹細胞、幹細胞及免疫細胞實驗操作及產品製程生產操作 

2. 協助研究開發新產品及測試確效 

3. 產品品管及檢驗 

4. 協助收集和分析產品設計資料，研究產品發展趨勢，跟進行業動態及政策 

5. 協助特管法、人體試驗、新產品行銷企畫案專業內容撰寫 

6. 協助研發團隊的資源管理、人員調配和培訓 

7. 支援公司其它事項及主管交辦事項

1.協助健康食品及特殊營養食品查驗登記案之審查及諮詢業務 

2.法規科學資料彙整  

3.審查及諮詢之案件管理 

4.會議籌備及辦理 

5.其他臨時交辦業務  

學歷要求：國內外大學食品、營養、藥學或醫學相關領域碩士學位畢業 

請至本中心網站【加入CDE】專區了解更多職缺訊息： https://www.cde.org.tw/joincde/1409/1999/13531/jobList

1.實驗規劃執行、膠液配製/記錄/分析 

2.調色與對色相關作業 

3.儀器設備詢價與請購相關作業 

4.課內行政、教育訓練相關作業 

5.其他主管交辦

General Description:  

Develop clinical trial related documents for submission to regulatory authorities and/or IRB.  

Clinical documents, including but not limited to: 

1. Clinical study protocols and amendments,  

2. Investigator brochures,  

3. Clinical study reports,  

4. Regulatory briefing documents, 

5. Informed consent form 

6. Clinical sections of INDs, NDAs, and  

7. Other regulatory/IRB submission documents.

1、具備基礎製劑技術 

2、進行實驗批次設計、開發與放大批次處理 

3、產品製程設計 

4、製程放大及產品量產產線導入 

5、產品主檔案(master file)、通用技術文件建立 

6、主管交辦事項

國外產品查驗登記

1.抗病毒研究等相關實驗規劃與操作 

2.文獻搜尋與分析整理 

3.具抗病毒研究等實驗操作實務經驗 

例如: plaque reduction assay、western blot、IFA、TCID50、qPCR等。 

4.其餘主管交辦事項 

5.將視工作經驗調整薪資待遇

應徵項目：博士後研究員乙名 

工作地點：國家衛生研究院(竹南科學園區)––-李華容 (Hua-Jung Li)博士實驗室 

工作性質：間質幹細胞、癌症幹細胞、幹細胞外泌體相關研究及治療應用(Biology and application of mesenchymal stem cells, cancer stem cells, stem cell derived exosomes) 

應徵條件： 

1. 具生物、醫學相關學科畢業之博士學位。  

2. 具備細胞培養、分子生物、動物實驗經驗者佳。 

3. 具學術研究熱誠、責任感、團隊合作精神及備良好溝通能力，並對前途規劃有想法。 

工作待遇：依依國家衛生研究院計畫下博士後研究員相關規定。 

意者請備妥個人履歷、自傳(中英文不拘)、提供推薦人(1-2位，含姓名、職稱、與被推薦人關係及聯絡方式)，以電子檔方式傳送至李華容博士: annli@nhri.edu.tw；請註明應徵李華容博士實驗室；合者約談，恕不退件。 

聯絡電話：翁小姐，(037) 206-166分機38303

*研究方向: 探索中草藥及腸道菌應用於癌症治療與臨床應用之潛能  

*博士後研究員需求- 

具小鼠癌症疾病模式建立經驗, 或是大數據分析經驗 

*碩士級助理需求- 

1. 有動物實驗操作經驗 

2. 細胞培養，操作一般分生與生化實驗 

3. 安排、聯繫並執行研究計畫，進行計畫內容工作項目、文獻彙整、撰寫實驗記錄  

4. 協助處理實驗室日常事務 

*學士級助理需求- 

1. 有細胞培養及分生操作經驗 

2. 不排斥動物實驗操作 

3. 安排、聯繫並執行研究計畫，進行計畫內容工作項目、撰寫研究成果報告  

4. 協助處理實驗室日常事務

1、協助學術單位實驗室售後問題協助及支援 

2、協助製作有關產品行銷與策略等相關文宣 

3、協助訓練教育銷售人員產品知識 

4、協助新產品行銷策略定義與開發 

5、國內外廠商聯繫之問題客服回覆及諮詢 

6、收集國內市場產品訊息，分析趨勢，研究客戶開發方向 

7、定期參加國外原廠專業培訓課程. 

8、年薪保障14月薪(含年終)

1.理化性檢驗分析 

2.儀器分析 

3.微生物相關檢驗 

4.分析方法確效 

5.GMP相關文件處理

1.藥品之配方設計與製程開發。 

2.藥品查驗登記技術資料(CTD)撰寫。 

3.會同生產技術人員進行量產放大。 

4.協助專利檢索、解讀、迴避、及協助侵害鑑定報告書與專利申請書之技術資料彙整。

1.推動國際化粧品GMP驗證之合作與服務 

2.協助化粧品法規計畫訓練課程業務 

3.協助化粧品法規研究及撰寫研究報告

1.計劃與執行保養品新配方的開發測試流程 

2.分析保養品原料的特性並提出創新應用方案 

3.監督並改善保養品生產過程中的品質問題 

4.撰寫研發報告與技術標準作業文件 

5.協調研發團隊進行實驗與結果分析討論 

6.引進新保養品技術並評估市場應用潛力 

7.GMP 22716建置與維護

1.微生物檢驗相關工作 

2.其他主管交辦事項