Associate Regulatory Affairs Manager

2 weeks ago


Hanoi, Hanoi, Vietnam Abbott Laboratories Full time

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
  • 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

Language Skill:

  • Vietnamese/ Tiếng Việt
  • English/Tiếng Anh

Computer Skill:

  • MS office


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