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.
• Bachelor with University of Pharmacy or Medical
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
18 Luy Ban Bich, Tan Phu Dist, HCMC
Talent Acquisition Team
Company profile: Abbott Vietnam was established in the year 1995. Since then, it has undergone extraordinary development and was soon perceived as one of the premier healthcare providers in the market. Abbott Vietnam provides a superior range of customer-focused healthcare solutions, built on credible science and values. Our diverse family of pharmaceutical, medical and nutritional products... View more