Regulatory Affairs Executive (Ha Noi)

At least 1-year experience in Regulatory Affairs in Pharmaceutical Industry, MNCs organization is preferred.
• Be able to work independently in registration dossier preparation
• High attention to details
• Deals well with ambiguity, proactive and a quick learner, strong team spirit
• High level of integrity with good ethical core values.
• Effective communication, organization and planning skills
• Fluency in English

• Laptop
• Chế độ bảo hiểm
• Phụ cấp
• Chế độ thưởng
• Đào tạo
• Tăng lương
• Công tác phí
• Nghỉ phép năm

Working Location: Handi Resco Tower, Kim Ma, Ba Dinh, Ha Noi
Prepare registration dossiers products following the local regulations and Company policies. Submit registration dossiers to MoH as time manner.
• Perform maintenance activities depending on local or regional requirements such as variation on CCDS or CMC, renewal of MAA in VN.
• Perform and follow up until approval for promotional materials for respective products in Vietnam.
• Co-ordinate with relevant functions e.g. Logistic, Commercial with support from line manager to ensure supply continuity and mitigation plan for any business impact due to product license issues.
• Involve in relevant regulatory systems
• Regulatory Compliance to ensure local implementation and compliance with Corporate Policies, Processes, Procedures and Guidelines relevant to RA activities.