Associate Regulatory Affairs Manager - Abbott Pharmaceuticals

Associate Regulatory Affairs Manager - Abbott Pharmaceuticals

Abbott Nutrition Health Institute (ANHI)
3-6 years
Not Specified

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/ Ting Vit & English/Ting Anh
Computer Skill: MS office

MINIMUM EDUCATION REQUIRED
. Pharmacist/or Bachelor's degree/or Medical Doctor

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