developing, the Finance Controller will take the lead in regulatory and administrative groundwork—such as assisting with

R&D, Regulatory, Sales, and Supply Chain teams to ensure smooth product development, launch, and commercialization. 3.

Understanding of the lifecycle of drug products and basic GMP workflow 3. Actively involved in the regulatory submission process 4.

can be home base 無任務指派時，視情況返回總公司，以外勤及在家備勤與其他公司指派的任務為主 9. Prepare the Food related training courses/Q&A, and to be the

Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the

Job Summary Completes and maintains regulatory approvals and clearances of assigned products. Job Responsibilities

to employ an Associate Scientist - Food Chemistry, to strengthen the research capacity of the Center's chemical analysis

innovation. The company provides end-to-end services, including regulatory strategy, clinical protocol design, technology

. Develop and review documentation for accuracy and consistency with regulatory strategy to ensure completion of high-

technical and regulatory expertise, assisting in resolving product development and regulatory issues (提供技術和法規方面的專業建議，協助解決產品

manage product development status and handle outsourced items correlated to project activities。 5.Support regulatory

區之食材備料與補貨 Collect used cafeteria trays and utensils 整理收回餐廳使用的餐盤及餐具 Clean the serving line and kitchen food prep areas.

1) 主導內外部稽核，包含國外客戶、各國政府單位、第三方公證單位之稽核活動 2) 持續推動內部品質系統之改善，確保法規符合性並滿足客戶要求 3) 更新及維護法規註冊相關文件 4) 主管交辦事項

process to produce animal-free food products. 2) Analyze product candidates and improve the formulations. 3) Scale up the

Job Summary: Prepare food and serve our customers to ensure our food service department runs smoothly. 準備食物並為顧客提供服務，以確保餐廳部

About this opportunity The APAC Regulatory and Quality Assurance Department has a position based in Taiwan for a RA part-

◆ Ensure NB/AIO/DT products comply with WW safety/EMC/Environmental/RF regulatory requirements, especially in Environmental

example in relation to food safety,production, quality, efficiency and range presentation to ensure our guests enjoy a tasty

Prepare regulatory documentation for software/AI medical devices - Track global regulations and support submission

1. 職責與職位要求： *審查NDA/ ANDA製劑相關文件，確保其符合國際和地區監管標準 *與內部團隊協調，確保產品的合規性和註冊進度 *熟悉各國監管要求，確保提交的文件遵守各地的法規 *參與審查過程中的跨部門協作，確保項目的有效執行 2. 資格與技能要求： *具藥學、化學或相關領域背景 *至少有1年以上的藥品審查經驗 *了解國際藥品監管要求，包括ICH、FDA、EMA等 *強大的問題解決和溝通能力，能夠應對複雜的監管挑戰與協調合作

1. 醫療器材、藥品查驗登記申請、更新及展延 2. 技術文件彙整、撰寫及更新 3. 原料進口許可申請 4. 其他: 主管交辦事宜

職務內容 1.醫療器材產品查驗登記申請相關事務 2.品質系統管理(QSD)申請及相關事務 3.醫療器材法規更新相關事務 4.英文書信及基本口語溝通能力 5.其他法規相關或交辦事項 *有以下條件尤佳， 1.於醫療器材製造業或販賣業，從事醫療器材製造或醫療器材查驗登記文件資料準備、程序管理及送件實務相關業務一年以上。