Job Description
- Monitor assigned product registration plans, request relevant departments to provide necessary documents and related papers on time
- Check the completeness and compliance of documents; detect any errors, deficiencies, or regulatory non-conformities (if any) and request corrections/supplements from related departments
- Draft and prepare registration dossiers and other submissions (new registration, renewal, variation applications, etc.) in accordance with current regulations and requirements
- Submit registration dossiers to the Drug Administration of Vietnam (DAV) — Ministry of Health
- Follow up the status of dossiers before and after submission
- Prepare supplementary dossiers as required by the DAV — Ministry of Health
- Handle post-registration tasks once product licenses or approvals for variations are granted
- Prepare monthly/quarterly work progress reports
- Perform other tasks as assigned by the RA Manager
Job Requirements
- Bachelor’s degree in Pharmacy, Chemistry, or Biotechnology
- Minimum 2 years of experience in pharmaceutical registration and regulatory affairs
- Good command of pharmaceutical English
- Proficient in Microsoft Office
- Honest, well-organized, disciplined, and highly responsible
- Careful, hardworking, with good teamwork skills
Benefits
- Competitive salary based on ability
- 13th-month salary and annual salary review according to company policy
- Paid annual leave, public holidays, and New Year holidays as regulated
- Full participation in Social, Health, and Unemployment Insurance according to state regulations
- Opportunities to attend professional training courses
- Provided with full working equipment
- Annual health check-ups
- Participation in company teambuilding and travel programs
- Professional working environment with many opportunities for development and promotion
- Free lunch, coffee, tea, and snacks during breaks at the company
Workplace
- Ho Chi Minh City: Lot E9-3a, Street No.1, Hiep Phuoc Industrial Park, Hiep Phuoc Commune, Nha Be District, Ho Chi Minh City
Working Hours
- Monday to Friday: 07:15 AM to 04:20 PM
- 1 Saturday per month