Bien Hoa, VNM
1 day ago
Regulatory Affairs Executive (Nutrition) - Dong Nai
Working Location: Bien Hoa, Dong Nai **_MAIN PURPOSE OF ROLE_** 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. **_MAIN RESPONSIBILITIES_** + 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 **_MINIMUM BACKGROUND/ EXPERIENCE REQUIRED_** **_Work_** **_Experience_** At least 1 year of experience in overall Nutrition/ Pharmacy/ Medicine industry or specific in regulatory affairs **_Education_** Bachelor's degree: Pharmacy, Nutrition or Medicine. **_CORE Skills Required_** + 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/manager + Good technical knowledge on nutrition or pharmacy or medicine. _Behavioral / Leadership Skill_ Adaptability, Initiative, Innovation, Integrity, Teamwork _Language Skill_ English B1 (Reading, Writing, Listening, Speaking) _Computer Skill_ Microsoft office An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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