Offers “Abbott”

Expires soon Abbott

Associate Regulatory Affairs Manager (Pharma Division - Based in Hanoi)

  • Hà Nội, Việt Nam
  • Teaching

Job description

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
 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
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

Behavioral / Leadership Skill: Apply Abbott Capabilities Framework
Language Skill:
• Vietnamese/ Tiếng Việt
• English/Tiếng Anh

Computer Skill:
• MS office

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

        

LOCATION:

Vietnam > Hanoi : Handi Resco Tower

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Make every future a success.
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