I. Major Responsibilities:
1. 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
2-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
II. Qualifications/Experience (Required Knowledge, Skills, Education, Relevant Experience):
- Bachelor's degree of Pharmacy
- Having experience in the pharmaceutical industry in regulatory affairs
- MS Office (Outlook, PowerPoint, Excel and Word) proficient
- Bilingual in English and Vietnamese (written, spoken)
III. Competencies:
- Strong administration and attention to detail
- Good communication and interpersonal skills
- Ability to consistently meet deadlines
IV. Benefits:
- Annual salary review
- 13th month bonus + KPI incentive
- 24/7 healthcare insurance
