Regulatory Affairs Executive (Nutrition) - Dong Nai
Abbott
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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