![Abbott Laboratories](https://media.trabajo.org/img/noimg.jpg)
Associate Regulatory Affairs Manager
2 weeks ago
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.
MINIMUM BACKGROUND/ EXPERIENCE REQUIRED
- Work Experience:_ >3 years experience in Regulatory, prefer pharmaceutical MNC
- Education_
Education Level:
Pharmacist/or Bachelor's degree/or Medical Doctor
- 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
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