LUXASIA_盧亞股份有限公司
Senior Regulatory Affairs Executive
10/17 Updated
Full-time
Mid to Senior Level
English Required
0 ~ 5 applicants

Salary & Location

Salary negotiable
(Regular monthly salary of NT$40,000 or above)
台北市松山區

Required

Language Requirements
English
聽/精通、說/精通、讀/精通、寫/精通
Work Experience
2年以上

Job Description

CORE RESPONSIBILITIES
OPERATIONAL REGULATORY
• Create login access with TFDA and manage e-notification process for general cosmetics and special cosmetics
• Create e-notification files following notification exemptions rules as set by TFDA
• Review product technical dossier against list of TFDA prohibited and restricted ingredients , liaise with principal parties to resolve issues relating to submission dossier
• Establish PIF creation for all categories
• Coordinate with Brand principle and LUXASIA regulatory teams to compile GMP statements
• Maintain a Master Registration tracker with full traceability to Notification Cert and Submission data
• Review existing Labels for compliance to labeling guideline
• Maintain Change management process for actively notified products in TWN
• Act as Luxasia PIC for all TFDA surveillance audits
STRATEGIC REGULATORY
• Work with inhouse Demand Planners and Marketing Leads to identify and develop Quartely based priority list for PIF compilation
• Create Master Label Drafts for non EN artworks.
• Create a system to track and update Legal colourant list and Prohibited Ingredient List
• Work with Demand Planner Team to ascertain sale-flow data are tracked. Draft a recall process flow that can be used in cases of recalls required by Post Market Surveillance Units
• Print all Notification certificates for existing and new products and create a safe Repository through available domains.
• Ensure DOM, Shelf Life printing/EXP date printing are accurately practiced by warehouse (local or SG DC)
• Review small size products with labelling space below 40 cm2 are in compliance to labeling law.
Recruitment Privacy Notice
By proceeding with your application, you confirm that you have read LUXASIA's recruitment privacy notice [https://www.luxasia.com/recruitment-privacy-notice/] and consent to the LUXASIA group collecting, processing and disclosing your personal data for purposes specified in the notice.
招聘個資保護聲明:
針對您應聘盧亞職位所提供的個人資訊,您確認您已閱讀LUXASIA的招聘個資保護聲明內容[https://www.luxasia.com/recruitment-privacy-notice/], 並同意 LUXASIA 集團收集、處理和利用所提供予本公司之個人資料,本公司將依誠實及信用之方法,於符合蒐集之目的及特定目的之必要範圍內,蒐集、處理利用您的個人資料。
Number of Openings
1~1人
Educational Requirements
大學(學院)以上
Field of Study Requirements
醫學系相關、醫學技術及檢驗相關、藥學相關
Work Schedule
9:00-18:00
Leave Policy
週休二日

Job Skills

Inspection of Legal Validity of Various Documents
Inspection of Legal Records and Related Documents
Familiarity with Pharmaceutical Administration and Regulations
檢驗各項文件之法律效力 檢驗法律紀錄和相關文件 熟悉藥事行政與法規
Job Category
Legal Affairs
Compliance Officer
Other Legal Professionals
【About Us】 LUXASIA is the leading beauty omnichannel distribution platform of Asia Pacific that has successfully enabled brand growth for more than 120 luxury beauty brands. Our integrated brand-building capabilities include luxury retail, online commerce, consumer marketing, and supply chain management. Since 1986, the company has partnered the world’s finest brands, such as Aveda, Bvlgari, Calvin Klein, Diptyque, Hermes, La Prairie, Montblanc, and SK-II. We have also established Joint Ventures with the likes of LVMH Group, Elizabeth Arden, Puig, Yves Rocher, and By Terry. At the core of our business is a diverse and dynamic #OneTeam of 2000 talents that shapes the face of luxury beauty, and delights consumers daily across our growing footprint of 15 markets. Come join us now. 【Why Join Us?】 At LUXASIA, we believe there is beauty within every talent – that is you. We grow you by building your competencies and unleashing your potential. We have curated a vast portfolio of over 100 luxury brands across Asia Pacific and growing. Your work will enrich the lives of millions of consumers across the region. With us, you get to be an entrepreneur, running the business like it is your very own. We give you autonomy but not without guidance and genuine care. We are a diverse and inclusive team that is courageously innovative. Together as #OneTeam, we celebrate differences, embrace change, explore new ideas, take risks, fail fast, and drive results. While challenges at work are inevitable, the journey promises to be fulfilling. With LUXASIA, an exciting career filled with robust professional growth awaits you. Isn’t that beautiful? 【 Recruitment Privacy Notice ?】 By proceeding with your application, you confirm that you have read LUXASIA's recruitment privacy notice [https://www.luxasia.com/recruitment-privacy-notice/] and consent to the LUXASIA group collecting, processing and disclosing your personal data for purposes specified in the notice.
0 ~ 5 applicants