Regulatory Affairs Manager
Consultant Nu Ho
Date posted 01 January 2023ha-noi healthcare/regulatory-affairs 2023-01-10 2023-03-02 pharmaceuticals Hanoi Hanoi VN Robert Walters https://www.robertwalters.com.vn https://www.robertwalters.com.vn/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png true
A exciting Regulatory Affairs Manager role in a multinational pharmaceutical company is available and ready for 2023 business.
About the Regulatory Affairs Manager Role:
Report to Regional Regulatory Affairs Director, this role will plan, direct, and monitor regulatory affairs so that the organisation has the permits, license, certificate, authorisation, and other approvals it needs to conduct its current and future business activities.
- Primary contact with DAV, MOH and relevant authorities
- Liaise with government to ensure regulatory compliance
- Establish and maintain positive relationship with government agencies and other regulatory authorities
- Liaise with functional managers to understand their short to medium-term business goals and develop plans, cost estimates, schedules for acquiring the necessary permits/ approvals
- Ensure the organisation regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations/ laws and standards
- Assure all audits so that organisation and government standards on products/ processes are met
- Supervise the registration of marketed product
- Monitor and disseminate information on changes to regulations affecting registration, manufacture, distribution and sale of products
- Provide consultation where needed to operations, QA and commercial team
To succeed in the role, you should have at least five years of experience in Vietnam pharmaceutical regulatory.
- Pharmacist background
- At least five years of experience in regulatory affairs roles, experience in QA is a plus
- Good English communication
- Dynamic and proactive
This firm has an outstanding international reputation in its field and great value is placed on training and development.
If you are talented and focused 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.