Hồ sơ ứng viên

I. Activities related to Ha Noi Office:

• Processing proposal and payment for all expenses related to drug registration (registration fee, translation, photocopy, notarization, etc.) and Hanoi office expenses,
• Managing day-to-day transactions and track in expenses tracker,
• Monitoring regulatory environment and update any changes,
• Coordinating some Novartis’s event such as the Community Partnership Day, Quality Matter Day, Health Checkup, Mid-Autumn
II. Activities related to drug regulatory affair:
>> FROM 09/2018 – Present:
• Handle: variation dossiers, GMP-EU/PICs, maintaining visa numbers;
• Closed partnership with expert at MOH to follow status of submitted dossiers;
• Submit all dossiers online;
• Have knowledge of local regulatory requirements and processes;
• Co-work with related functions to ensure delivery the best supportive
• Manage training records
>> FROM 12/2015 – 09/2018:
• Preparing registration dossier, assist preparing registration forms, documents and submit to Drug Administration of Vietnam (DAV),
• Manage: response letters from DAV, Legal documents management (CEPs, CPPs, GMPs, Trademarks, MAs or LA).
• Co-work with all vendors which support DRA activities such as: notarized, translation documents.