Senior Regulatory Affairs Executive - Abbott Pharmaceuticals (Hanoi)

MAIN PURPOSE OF ROLE:
Handle process of registration of new products, maintenance of all approved products in Vietnam and operate marketed products according to local regulations.
MAIN RESPONSIBILITIES:
Registration of New and Existing Products
• Effects 6- 9 months registration plan
• Initiates/monitors/updates Regulatory Report in timely manner
• Weekly follow up with the authorities as needed.
• Ensures availability of updated registration documents/samples
• Reviews and compiles registration dossier for prompt renewal/initial registration
• Fast requisition of dossier and check requests
Registration of Promotion Materials
• Register and compiles registration dossier for promotional material
• Ensures all promotional materials are lawfully compliance
Regulatory Intelligence
• Inform head of Department/contacts all change and upcoming new regulations.
• Implement new regulation properly.
• Be aware of coming new regulation/change that impact to regulatory or business
Regulatory Compliance
• Ensures application of special permits and import certificates at MOH.
• Keeps registration record updated at all times and promptly submits books and records as per schedule
• Ensures that all exempt regulated products are MOH verified prior to production use
• Ensures that all product labels/package inserts are updated as approved by MOH’s regulation.
Cross- function Support
• Ensures correctness of received documents vs information submitted
• Ensures prompt coordination with other departments/units such as Sales & Marketing on regulatory and corporate matters
Administrative
• Keeps updated files of MoH Regulations
• Maintains proper filing of protocol and other regulatory and clinical related documents
• Ensures that all technical documents/dossiers and registration samples are kept in secured place

Training & Development
Premium Healthcare
13- month salary & annual performance bonus

Cập nhật gần nhất lúc: 2026-01-25 03:50:02