Associate Regulatory Affairs Manager
Salary VND50,000,000 - VND65,000,000 per month + Phone
Consultant Que Anh Nguyen
Date posted 02 August 2022ha-noi healthcare/medical-affairs 2022-08-02 2022-10-01 pharmaceuticals Hanoi Hanoi VN VND 50000000 65000000 65000000 MONTH Robert Walters https://www.robertwalters.com.vn https://www.robertwalters.com.vn/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png
As a result of ongoing and continued successes both within Vietnam and internationally, this global leader in pharmaceutical industry is recruiting a Associate Regulatory Affairs Manager to join the office based in Hanoi, Vietnam.
About the Associate Regulatory Affairs Manager Role:
Reporting to the Regulatory Affairs & QA Director, you will be responsible for / will lead / will play a key role in product registration, including new, renewal, and variants, as well as special import licenses and promotional materials as long as performing regulatory actions to boost market product circulation.
- Contact with DAV, MOH, and other necessary authorities such as liaise with the government to guarantee regulatory compliance, establish and maintain strong relationships with government agencies and other regulators
- Work with the manufacturer and the area to produce a dossier for product registration (drug, health supplement, etc.) in accordance with the regulations. Monitor the registration of a marketed product.
- Liaison with multiple distributors/consultants/DAV (Drug Administration of Vietnam) to ensure the registration process runs smoothly
- Understand and discuss current DAV regulations/new guidelines/circulars updates. Monitor and disseminate information on changes to regulations affecting the registration, manufacture, distribution, and sale of company products
- Evaluate and analyse registration dossiers for administration; and maintain registration status, submissions, and registration timelines
- Closely monitor the status of the application from the time it is submitted until it is approved
- Assist the Marketing team in obtaining advertisement licenses and detail aid material printing permits
To succeed in this Associate Regulatory Affairs Manager, you will need to have at least three years of experience in Regulatory, prefer pharmaceutical MNC, with Pharmacist/or Bachelor’s degree/or Medical Doctor.
- Time management
- Good in working arrangement, teamwork
- Honest, careful, patient, highly responsible
- Language Skill: Vietnamese/ Tiếng Việt & English/Tiếng Anh
- Computer Skill: MS office
A worldwide pharmaceutical and health-care corporation whose primary goal is to assist people to live their lives the best possible with greater health.
If you have a successful track record of regulatory affairs, specially with imported products and want to take the next step in your career, this is the role for you.
Apply now or call me to discuss this new opportunity.
Due to the high volume of applications we are experiencing, our team will only be in touch with you if your application is shortlisted.