Associate Regulatory Affairs Manager - Abbott Pharmaceuticals

Job description

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.

JOB REQUIREMENTS

MINIMUM BACKGROUND/ EXPERIENCE REQUIRED
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

MINIMUM EDUCATION REQUIRED
• Pharmacist/or Bachelor’s degree/or Medical Doctor

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

EPD Established Pharma

        

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)