Regulatory Affairs Assistant (Contractor)

Estee Lauder Vietnam · Hồ Chí Minh

Loại hình

Toàn thời gian

Hình thức

Tại văn phòng

Cấp bậc

Nhân viên

Ngành nghề

Ngành nghề khác

Mức lương

Thương lượng

Địa điểm

Hồ Chí Minh, Hồ Chí Minh, Hồ Chí Minh

Tổng quan

Support all RA processes to ensure compliance:
Support Product Notification process for NPL (New product launch) & EPL (Exist product launch) by :
Check ingredients to ensure the compliance of formula.
Prepare dossiers for notification submission & obtain notification approval and filing the Master Notification file.
Collect data from Regone/PDS and share to agency for notification preparation & submission.
Follow up closely with Drug Administration Vietnam (DAV) to update status of submitted notification.
Request CFS & LOA for products.
Update final name on CFS to master file.
Check all data of products in RegOne /PDS/RDS systems and upload data to Regone systems.
Manage product data in system, processing file, master file, Noti list…
Connect with global team to collect supporting data for registration
Register cosmetic sample for sample import.
Support Vietnamese labelling:
Check & update new Vietnamese labelling to master file.
Request APAC to create new content labelling (if any).
Administration tasks:
Proceed payment to DAV and agency and proceed payment for vendor
Follow up with those Authority to collect invoices.
Provide notification number to stakeholder (internal team,….) when having any request.
Other tasks: as assigned by line manager.

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