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【公司名称】
就业情报资讯股份有限公司
【工作职缺】
约聘法规事务专员 Contract Regulatory Affairs Specialist (知名外商药厂，派驻
Viatris晖致医药)
【工作内容】
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.
【征求条件】
工作经验：3年以上
学历要求：大学、硕士
科系要求：药学相关、化学相关、生物学相关
语文条件：英文(听:精通、说:精通、读:精通、写:精通)
擅长工具：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.
【工作地点】
台北市信义区信义路5段7号27F
【工作时间】
周一~周五，9:00-18:00
【月休】
周休二日
【公司福利】
1.享劳保、健保、劳退
2.员工团保
【薪资范围】
面议(经常性薪资达4万元或以上)
【需求人数】
1人
【联络人/连络方式】
廖小姐 [email protected]
请E-MAIL：《履历表、自传、毕业证书》
【其他备注】
派遣公司对派遣员工并无抽成金额。