[Hanoi] RA-QA Associate (9-month contract)

II. Qualifications/Experience (Required Knowledge, Skills, Education, Relevant Experience):

- Bachelor’s degree of Pharmacy

- Having at least 1 year experience in the regulatory affairs positions for imported drugs

- MS Office (Outlook, PowerPoint, Excel and Word) proficiency

- 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

- Competitive salary

- Full insurance according to law

- Other benefit according to company policy

Working location: Lang Ha, Ba Dinh, Ha Noi

Working time: 8:00 - 17:00, Mon-Fri

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

- Update reports, systems as required

- Conduct the regulatory surveys, communicate with Regional for registration products

- 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