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.
Ngành nghề: Dược phẩm/ Hóa Mỹ Phẩm
Kinh nghiệm: 3 Năm
Cấp bậc: Trưởng nhóm / Giám sát
Hình thức: Nhân viên chính thức
Địa điểm: Hà Nội

Yêu cầu công việc

• 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.