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
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
Closely follow up the status of application from the time of submission until getting approval
Support Marketing team in applying advertisement licenses & detail aid material printing permits
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 Level: Pharmacist/or Bachelor’s degree/or Medical Doctor
CORE Skills Required:
• Time management
• Good in working arrangement, teamwork
• Honest, careful, patient, highly responsible
Behavioral / Leadership Skill: Apply Abbott Capabilities Framework
• Vietnamese/ Tiếng Việt
• English/Tiếng Anh
• MS office
Vietnam > Hanoi : Handi Resco Tower
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)