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【公司名稱】
就業情報資訊股份有限公司
【工作職缺】
約聘法規事務專員 Contract Regulatory Affairs Specialist (知名外商藥廠，派駐
Viatris暉致醫藥)
【工作內容】
Prepare, submit and follow assigned registration applications under
supervision of the Senior Regulatory Affairs Manager, to ensure that
marketing authorizations are obtained and maintained in line with the
business plan.
‧ Ensure to file new product(s) registration and update the current
registrations in a timely manner.
‧ Product life cycle management of the existing product licenses (including
drugs, medical devices, cosmetics and food supplements) to ensure all are
valid and compliance with local regulation.
‧ Maintain the accuracy of labelling, pack leaflets in accordance with local
regulations and corporate data sheet.
‧ Ensure accurate translations of relevant documents.
‧ Provide cross-functional support needs in the organization.
‧ Participate in workshops, symposiums related to regulatory affairs changes
at a country level; share with team members regarding the latest information
related to her/his works.
‧ Being able to propose solutions to different scenarios and discuss with
her/his direct report.
‧ Establish good networking with TFDA/CDE officers.
‧ Establish good networking with Global Regulatory Affairs colleagues with
regular contacts.
‧ Perform other duties as assigned by management.
【徵求條件】
工作經驗：3年以上
學歷要求：大學、碩士
科系要求：藥學相關、化學相關、生物學相關
語文條件：英文(聽:精通、說:精通、讀:精通、寫:精通)
擅長工具：Excel、Outlook、PowerPoint、Word
【Education & Experiences】
‧ University graduated or above with pharmacy or scientific related
background essential.
‧ At least 3 years of experience in regulatory affairs.
‧ Regulatory knowledge of Taiwan laws and regulations in pharmaceuticals,
medical device, cosmetics, food supplements and PIC/S GMP.
【Core Competencies & Skills】
‧ Excellent interpersonal, presentation, listening, communication and
project/time management skills.
‧ Ability to manage multiple priorities and deliver accurate outcomes.
‧ Able to actively analyze and take quick action without compromising
quality; utilizes effective negotiation skills.
‧ Shows integrity, tenacity, resilience and adaptability in complex
situations; able to handle pressure and commit to and respect deadlines.
‧ Demonstrates cooperative attitude both among team members and with other
colleagues in the company.
‧ Self-motivated and able to work independently.
‧ Demonstrates good English and Chinese language skills both in written and
oral.
【工作地點】
台北市信義區信義路5段7號27F
【工作時間】
周一~周五，9:00-18:00
【月休】
周休二日
【公司福利】
1.享勞保、健保、勞退
2.員工團保
【薪資範圍】
面議(經常性薪資達4萬元或以上)
【需求人數】
1人
【聯絡人/連絡方式】
廖小姐 [email protected]
請E-MAIL：《履歷表、自傳、畢業證書》
【其他備註】
派遣公司對派遣員工並無抽成金額。