Regulatory Affairs

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20 years experiences on regulatory activities in Vietnam .Lead and provide strategic oversight of execution of all regulatory filing activities across product lifecycles
Shape the regulatory environment by taking a leadership role in industry associations on regulatory policy and regulations; taking regulatory convergence into consideration
Contribute to and influence global regulatory strategies, considering local regulation and business needs
It is included :
• Company licence
• Product registrations
• Pack Management for country specific make up comply with local requirement
• Local Redressing for imported products
• Promotional materials - vetting and application for approval
• Regulatory compliance , PV compliance
• Regulatory information/updates–regulatory policies/regulations, competitors’ information
• Special Import Permit/Quota applications - assist when necessary
• Listing product for brand name listing and listing GMP-EU/PICs to support hospital tender