JOB SUMMARY:

This role focuses on Regulatory Affairs, including product registration with MOH and ensuring compliance with legislation, as well as Quality Assurance, managing product quality complaints and monthly reconciliation.

RESPONSIBILITIES:

• Regulatory Affairs:
• Prepare, submit, and follow up the product’s registration with MOH.
• Cooperate with relevant departments (marketing, field force) to prepare and submit the products brochure to get approval of MOH.
• Keep up to date with changes in regulatory legislation and guidelines.
• Update reports, systems as required.
• Other tasks assigned by manager.
• Quality Assurance:
• Receive product quality complaint (PQC) within Vietnam and report to manufacturer and OIAA-QA.
• Monthly reconciliation with distributor for PQC.
• Update reports, systems as required.

REQUIREMENTS:

• Bachelor’s degree of Pharmacy.
• Having experience in the pharmaceutical industry in regulatory affairs.
• MS Office (Outlook, PowerPoint, Excel and Word) proficiency.
• Bilingual in English and Vietnamese (written, spoken).
• Strong administration and attention to detail.
• Good communication and interpersonal skills.
• Ability to consistently meet deadlines.
• To succeed in this role, essential skills include: proficiency in MS Office, knowledge of Tiếng Anh, experienced with Kỹ Năng Giao Tiếp, able to use Excel and MS Word.
• Additionally, candidates should have knowledge of: QA/QC, understanding of Dược Sĩ, strong grasp of Dược phẩm, knowledge related to QA/QC Manager and Y Tế.

BENEFITS:

• Annual salary review.
• 13th month bonus + KPI incentive.
• 24/7 healthcare insurance.
• Chăm Sóc Sức Khỏe.
• Thưởng Tháng 13.