RESPONSIBILITIES

1. Support all RA processes to ensure compliance:

Support Product Notification process for NPL (New product launch) & EPL (Exist product launch) by :

o Check ingredients to ensure the compliance of formula.

o Prepare dossiers for notification submission & obtain notification approval and filing the Master Notification file.

o Collect data from Regone/PDS and share to agency for notification preparation & submission.

o Follow up closely with Drug Administration Vietnam (DAV) to update status of submitted notification.

o Update final name on CFS to master file.

o Request CFS & LOA for products.

o Check all data of products in RegOne /PDS/RDS systems and upload data to Regone systems.

o Manage product data in system, processing file, master file,…

Support Advertising License process:

o Prepare all advertising documents & submit to Department of Health HCM (DOH HCM).

o Follow up with DOH HCM to update status of submission.

Support Vietnamese labelling:

o Check & update new Vietnamese labelling to master file.

o Request APAC to create new content labelling (if any).

2. Administration tasks:

o Proceed payment to DAV and agency.

o Follow up with those Authority to collect invoices.

3. Other tasks: as assigned by line manager.

▪ Regulatory Affair experience 1-2 years.

▪ University Degree or College Degree with major Biology Technology/ Chemical/ or relevant major.

▪ Good-looking appearance.

▪ Good in English (written & speaking).

▪ Good communication skills, written and verbal.

▪ Good organizational skills, time management and follow up skills.

▪ Able to prioritize and handle several tasks simultaneously.

▪ Excellent Computer office skills. (excel)

• Degree: Bachelor
• Age: Unlimited
• Job type : Permanent
• Salary: Competitive