Associate Regulatory Affairs Manager - Abbott Pharmaceuticals

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
• 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.