Associate Regulatory Affairs Manager
5 months ago
**JOB DESCRIPTION**:
**MAIN PURPOSE OF ROLE**
- Product registration including new, renewal, variations, special import license, promotional materials
- Do regulatory activities to support product circulation in the market i.e. tender support, GMP listing, stock management
- Other tasks assigned by the line manager.
**MAIN RESPONSIBILITIES**
- Contact with DAV, MOH and relevant Authorities:
Liaise with government to ensure regulatory compliances.
Establish and maintain positive relationship with government agencies and other regulatory authorities.
- Coordinate with manufacture, region and prepare dossier for product registration (drug, health supplement ) following the regulation. Supervise the registration of marketed product.
- Liaison with various distributors/consultants/DAV (Drug Administration of Vietnam) to facilitate the smooth registration activity
- Understand and share current updates in regulations/new guidelines/circulars published by DAV
- Evaluate and review registration dossiers for administration
- Keep track of registration status, submissions and registration timeline
- Monitor and disseminate information on changes to regulations affecting registration, manufacture, distribution and sale of Abbott products.
**JOB REQUIREMENTS**:
**MINIMUM BACKGROUND/ EXPERIENCE REQUIRED**
Work Experience: 3 years experience in Regulatory, prefer pharmaceutical MNC
CORE Skills Required:
Professional Skill
- Time management
- Persuasiveness
- Good in working arrangement, teamwork
- Honest, careful, patient, highly responsible
Language Skill: Vietnamese/ Tiếng Việt & English/Tiếng Anh
Computer Skill: MS office
**MINIMUM EDUCATION REQUIRED**
- Pharmacist/or Bachelor’s degree/or Medical Doctor
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