Senior Regulatory Affairs Executive – Abbott Pharmaceuticals – Based in Binh Duong

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

Education
• University Degree (Medical Doctor, Pharmacist)
Experience
• More than 1 years relevant experience in regulatory affairs.
• Knowledge of regulations and standards.
Knowledge/ Skills
• Computer
• English
Others
• Continuous Improvement behavior

13 month salary & Incentive bonus

Premium Healthcare for personal & family

Training

Cập nhật gần nhất lúc: 2022-08-03 14:02:04