Associate Regulatory Affairs Manager (Import Product) – Abbott Pharmaceutical

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.

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

Behavioral / Leadership Skill: Apply Abbott Capabilities Framework

Language Skill: Vietnamese/ Tiếng Việt & English/Tiếng Anh

Computer Skill: MS office

• Pharmacist/or Bachelor’s degree/or Medical Doctor