Regulatory Affairs executive

• Prepare and submit pharmaceutical registration dossiers in Vietnam

• Manage new registrations, renewals, and variations

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

• Follow up dossier evaluation progress and respond to deficiency letters

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

• Bachelor's degree in Pharmacy.

• 3-5 years of experience in drug registration at a pharmaceutical company.

• Experience in preparing, submitting, and monitoring registration/renewal/variation dossiers at the Vietnam Drug Administration.

• Thorough understanding of drug registration regulations in Vietnam.

• Good English reading comprehension skills.

• Proactive and flexible in work.

Preference:

• Candidates currently working in Hanoi with experience working directly with drug regulatory authorities.