Regulatory Affairs Assistant

RESPONSIBILITIES
Support all RA processes to ensure compliance:
Support Product Notification process for NPL (New product launch) & EPL (Exist product launch) by :
Follow up closely with Drug Administration Vietnam (DAV) to update status of submitted notification.
Check all data of products in RegOne /PDS/RDS systems and upload data to Regone systems.
Collect data from Regone/PDS and share to agency for notification preparation & submission.
Check ingredients to ensure the compliance of formula.
Update final name on CFS to master file.
Manage product data in system, processing file, master file,…
Prepare dossiers for notification submission & obtain notification approval and filing the Master Notification file.
Request CFS & LOA for products.
Support Advertising License process:
Prepare all advertising documents & submit to Department of Health HCM (DOH HCM).
Follow up with DOH HCM to update status of submission.
Support Vietnamese labelling:
Check & update new Vietnamese labelling to master file.
Request APAC to create new content labelling (if any).
Administration tasks:
Follow up with those Authority to collect invoices.
Proceed payment to DAV and agency.
Other tasks: as assigned by line manager.

▪ Excellent Computer office skills. (excel)
▪ Regulatory Affair experience 1- 2 years.
▪ Good communication skills, written and verbal.
▪ Good organizational skills, time management and follow up skills.
▪ University Degree or College Degree with major Biology Technology/ Chemical/ or relevant major.
▪ Good- looking appearance.
▪ Good in English (written & speaking).
▪ Able to prioritize and handle several tasks simultaneously.

Laptop, Chế độ bảo hiểm, Du Lịch, Phụ cấp, Chế độ thưởng, Chăm sóc sức khỏe, Đào tạo, Tăng lương, Nghỉ phép năm

Cập nhật gần nhất lúc: 2024-08-13 13:50:03