Working Location : Bien Hoa, Dong Nai
The primary scope of the Regulatory Affairs Executive role is including :
- Execution : Ensure the implementation of RA strategies according to the guidance of the RA director / manager in preparing dossier and registering with the Health authority to obtain and maintain product licenses; product advertising certification; internal review promotional material to ensure compliance.Support other RA members in submitting Hard copy dossiers to Heath Authority in DongNai
- External engagement with Health authority : Follows up with Health authority to ensure product registration smoothly, got the product licenses on time with key claims protected.Frequently visit Health authority in Đồng Nai to establish a regular communication channel with Health Authority. Gather regulatory intelligence and report to RA director / manager.
- Cross-functional support : provide information related to regulation and product to support cross functions team.
- Preparing dossier for products registration, product advertising registration for in-charged product.
- Follows up, collect questions from Health authority, report and discuss with the manager to find appropriate answers to respond to Health authority.
- Gather regulatory intelligence
- Internal review promotion materials for in-charged product.
- Provide product technical information, regulation to support other functions
At least 1 year of experience in overall Nutrition / Pharmacy / Medicine industry or specific in regulatory affairs
Bachelor's degree : Pharmacy, Nutrition or Medicine.
Good communication skill : Clearly conveying information and ideas to Health authority to engages and helps them understand and accept company’s submission.Follow-up : Closely monitoring the product registration process and timely report to RA director / manager, respond to Health authority's request under instruction from RA director / managerGood technical knowledge on nutrition or pharmacy or medicine.Adaptability, Initiative, Innovation, Integrity, Teamwork
English B1 (Reading, Writing, Listening, Speaking)
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