← Abbott
Senior Regulatory Affairs Executive - Pharmaceuticals Division
Abbott · Bình Dương
Ứng tuyển tại trang chính thức ↗
Loại hình
Toàn thời gian
Hình thức
Tại văn phòng
Cấp bậc
Nhân viên
Ngành nghề
Dược phẩm
Mức lương
Thương lượng
Địa điểm
Bình Dương, Bình Dương, Bình Dương
Tổng quan
- Experienced professional individual contributor that works under limited supervision.
- Apply subject matter knowledge in the area of Regulatory Affairs.
- Require capacity to apply skills/knowledge within the context of specific needs or requirements.
- Handle process of registration of new products, maintenance of all approved products in Vietnam and operate marketed products according to local regulations.
- Registration of New and Existing Products
- Reviews and compiles registration dossier for prompt renewal/initial/ variation registration
- Ensures availability of updated registration documents/samples
- Fast requisition of dossier and check requests
- Initiates/monitors/updates Regulatory Report in timely manner
- Registration of Promotion Materials
- Register and compiles registration dossier for promotional material
- Ensures all promotional materials are lawfully compliance
- Regulatory Intelligence
- Be aware of coming new regulation/change that impact to regulatory or business
- Inform head of Department/contacts all change and upcoming new regulations
- Implement new regulation properly
- Regulatory Compliance
- 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.
- Keeps registration record updated at all times and promptly submits books and records as per schedule
- Cross-function Support
- Ensures prompt coordination with other departments/units such as Sales & Marketing on regulatory and corporate matters
- Ensures correctness of received documents vs information submitted
- Administrative
- Ensures that all technical documents/dossiers and registration samples are kept in secured place
- Maintains proper filing of protocol and other regulatory and clinical related documents
- Keeps updated files of MOH Regulations
Quyền lợi
Chăm sóc sức khỏe
Tóm tắt thông tin từ tin tuyển dụng chính thức. Xem bản gốc ↗
Quan tâm đến vị trí này?
Bạn sẽ được chuyển đến trang ứng tuyển chính thức của nhà tuyển dụng.
Ứng tuyển tại trang chính thức ↗
Đây là doanh nghiệp của bạn?
Nhận quản lý trang, yêu cầu chỉnh sửa hoặc gỡ bỏ
→