Regulatory Affairs Executive _ Glomed
Mô tả công việc
• Get product registration plan and assigned task directly from RA Manager.
• Percentage of unpassed/ rejected dossiers.
• Progress of registration dossier (except for delays from relevant departments).
• Refer to the products which have similar dosage form, strength, packing form, package material and shelf-life.
• Refer to reliable documents from official sources to find out clinical, pharmacology, pharmacokinetic characteristics… of active ingredient and product.
• Prepare leaflet with bilingual Vietnamese-English content.
• Prepare new domestic/ export drug registration dossiers according to current technique guideline and regulation.
• Prepare variation/ supplementary domestic/ export registration dossiers as requested.
• Prepare renewal domestic/ export drug registration dossiers periodically.
• Translate documents from Vietnamese into English and opposite way as requested.
• Search and update information about Drug/ Food supplement regulation as well as regulatory affairs.
• Ensure reliable and updated source.
• Follow up, receive information/ feedback from Drug Administration of Vietnam (DAV), Vietnam Food Administration (VFA) – Ministry of Health (MOH) about registration supplementary dossier, Decision of Visa number Issuance as well as approval official letter for changing/supplement.
• Understand information/ request and disseminate fully to relevant departments.
• Supplement as requests of authorities about drug/ food supplement registration fully and on time.
• Update regulation/ decision/ circular/ official letter related to product registration, manufacturing and circulation.
• Full information source, organized scientifically to search easily.
• Participate in preparing/ updating SOPs, forms and other documents related to regulatory affairs.
• Archieve, manage registration dossiers and other dossiers, documents..
Yêu cầu ứng viên
- Pharmacist Bachelor.
- At least 2 years experience at equivalent position.
- Organizational, job arrangements skills.
- Data analysis and processing skills.
- Writing and presentation skills.
- Proficient computer skill.
- English skill: Enough to search and understand English professional document and preprare English dossier as well as bilingual translation, English communication related to regulatory affairs.
Quyền lợi/Phúc lợi
- 13th month pay & Performance bonus
- Premium insurance
- Training program
Địa điểm làm việc
- Thành phố Hồ Chí Minh
- Tỉnh Bình Dương
| Quy mô: | 200-499 nhân viên |
| Lĩnh vực: | Chưa cập nhật |
| Địa chỉ: | Me Linh Point Tower, Level 9, 2 Ngo Duc Ke St., District 1, HCMC |
| Tên công ty: | Abbott Việt Nam |
| Quy mô: | 200-499 nhân viên |
| Lĩnh vực: | Chưa cập nhật |
| Địa chỉ: | Me Linh Point Tower, Level 9, 2 Ngo Duc Ke St., District 1, HCMC |
| Ngày đăng tuyển: | 04/09/2018 |
| Cấp bậc: | Khác |
| Học vấn: | Trung cấp |
| Số lượng tuyển: | 0 |
| Độ tuổi: | Không yêu cầu |
| Giới tính: | Không yêu cầu |
| Hình thức làm việc: | Toàn thời gian |
Thông báo
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