台灣大昌華嘉股份有限公司
【醫療 HEC】Senior Executive, Regulatory Affairs
9/30 Updated
Array
Full-time
Senior Level
English Required
0 ~ 5 applicants

Salary & Location

Salary negotiable
(Regular monthly salary of NT$40,000 or above)
台北市內湖區

Required

Language Requirements
English
聽/精通、說/精通、讀/精通、寫/精通
Work Experience
3年以上

Job Description

Regulatory Affairs
-Serve as a contact person for the client to communicate with the local health authorities
-Execute product registration and post-market changes to ensure compliance with local regulations.
-To maintain the validity of licenses, including but not limited to product and foreign manufacturers (PMF, DMF and QSD) licenses.
-Maintain product packaging, labeling and leaflet information to ensure compliance with local regulations.
-Management of pharmaceutical/medical device advertisements, including application, modification and extension of advertisements.
-Execute the business assigned by the senior manager of the Regulatory Affairs Department.
Drug/Medical Device Safety Surveillance Affairs
-Implement and maintain Pharmacovigilance and Medical Device Safety Surveillance System operation.
-Collect, archive, and manage all personal data document related to pharmacovigilance to ensure and protect data privacy according to SOPs and agreement.
General Affairs
Handle administrative affairs
Documentation and records management
-Formulate and revise the SOPs for the relevant affairs of the Regulatory Affairs
-Department, including but not limited product registration and Pharmacovigilance and Medical Device Safety Surveillance Systems.
Number of Openings
1~1人
Educational Requirements
大學(學院)以上
Field of Study Requirements
醫藥衛生學科類、食品營養相關
Work Schedule
09:00-18:00
Leave Policy
週休二日
Job Category
Compliance Officer
Other Legal Professionals
Other Medical Staff
台灣大昌華嘉股份有限公司
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Benefits
About DKSH 關於大昌華嘉集團 DKSH's purpose is to enrich people’s lives. For nearly 160 years, we have been marketing, selling, and distributing high-quality products and brands for multinational and Fortune 500 companies. Through our Business Units Consumer Goods, Healthcare, Performance Materials, and Technology, we deliver sustainable growth for our partners. We contribute to improving the quality of life for our employees and people in the local communities in which we operate. Headquartered in Switzerland, DKSH is publicly listed and operates in 36 markets across Asia Pacific, Europe, and North America. We employ over 29,000 specialists and produced net sales of CHF 11.1 billion in 2023. Learn more: https://www.dksh.com Why It’s Great to Work at DKSH At DKSH, we are driven by a purpose that goes beyond the ordinary: enriching people's lives. Through the products and services we provide, DKSH positively impacts millions of lives everyday. Join our team where entrepreneurship meets flexible work arrangements. Take the leap and start a journey where you can grow and make a difference! Delivering Growth – in Asia and Beyond. 大昌華嘉的企業目標是透過提供產品、服務和市場分析豐富每個人的生活。結合成為最信賴的夥伴之願景，我們的消費品、醫療保健、特用原料和科技事業單位不但在亞洲及世界各地為企業和品牌帶來成長、拓展業務，更透過我們代理的產品和服務供應醫院救命藥物、將優質產品帶到偏遠村莊、引進提升生活品質的科技設備、提供保健產品新配方讓生命更健康，進而豐富每個人的生活。與此同時，我們透過提供採購、市場分析、市場行銷和銷售、電子商務、配銷和物流以及售後服務幫助客戶與顧客一同成長和拓展。 在全球36個市場營運，聘僱超過29,000名專業人員，大昌華嘉是瑞士證交所公開上市的企業，2023年的銷售淨額為111億瑞士法郎。在1865年由瑞士創業家成立，大昌華嘉已經深根亞太地近160年，同時落實企業社會責任。 實現成長 – 專注亞洲 邁向世界
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