Mô tả công việc
- Prepare registration dossiers
- Prepare dossiers based on available templates for product registration
- Liaise with foreign pharmaceutical manufacturers (India, Turkey, Philippines, ETC.) to request necessary information and documentation
- Coordinate to track and expedite dossier progress for pharmaceutical products
- Receive deficiency letters, analyze them, and plan responses; compile, prepare, and submit supplementary dossiers
- Monitor and handle assigned drug circulation licenses; submit dossiers (variations, renewals) to ensure license continuity
- Handle and monitor product contracts between the company and suppliers
- Maintain relationships with existing suppliers and source new suppliers
- Report negotiation progress to management and support agreement signing
- Record and manage documentation and files
- Analyze and update current guidelines and regulations to ensure company compliance; provide general regulatory strategy advice
- Perform other tasks as assigned by the manager Detailed job scope will be discussed during the interview
Yêu cầu
- College degree or higher in Pharmacy or equivalent will be preferred.
- At least 1 year of experience in regulatory affairs or dossier registration
- Basic English skills: able to communicate, read, and write emails in English
- Proficient in Microsoft Office
- Ability to work independently and proactively
- Honest, careful, and detail-oriented
- CV must be submitted in English
Quyền lợi
- Salary: 12-16 million VND/month (depending on qualifications)
- 13th-month salary and year-end bonus (subject to be performances)
- Training and opportunity to work in a dynamic, professional, and friendly environment with career advancement opportunities
- Working hours: Office hours 8:30 AM - 5:30 PM Monday-Friday, 8:30 AM - 12:00 PM Saturday.
- Full working equipment provided
- Public holidays and leave in accordance with government regulations
Thông tin khác
Địa điểm làm việc
TP.HCM:83 Đường số 2, Phú Mỹ, Quận 7
Thông tin chung