Regulatory Affairs executive

• Meet authorities to do the necessary follow up of company product VISA approval/extension/renewal

• Manage new registrations, renewals, and variations

• Follow up dossier evaluation progress and respond to deficiency letters

• Prepare and submit pharmaceutical registration dossiers in Vietnam

• Double check with consultants on Artwork & pack insert which must be complied with labelling guidelines
• Accompanying & helping higher management to meet MOH authorities/experts during their Visit.
• Send work daily report to Chief Rep

• Proactive and flexible in work.
• Good English reading comprehension skills.
• Experience in preparing, submitting, and monitoring registration/renewal/variation dossiers at the Vietnam Drug Administration.
• 3- 5 years of experience in drug registration at a pharmaceutical company.
• Thorough understanding of drug registration regulations in Vietnam.
• Bachelor&039;s degree in Pharmacy.
Preference:
• Candidates currently working in Hanoi with experience working directly with drug regulatory authorities.

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Cập nhật gần nhất lúc: 2026-04-16 13:55:06