Associate Regulatory Affairs Manager – Abbott Pharmaceuticals (Based In Hanoi) Abbott

ROLES & RESPONSIBILITIES
MAIN PURPOSE OF ROLE
• Other tasks assigned by the line manager.
• 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…
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.
• Understand and share current updates in regulations/new guidelines/circulars published by DAV
• Support Marketing team in applying advertisement licenses & detail aid material printing permits
• 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.
• Closely follow up the status of application from the time of submission until getting approval
• Evaluate and review registration dossiers for administration
• Liaison with various distributors/consultants/DAV (Drug Administration of Vietnam) to facilitate the smooth registration activity
• Coordinate with manufacture, region and prepare dossier for product registration (drug, health supplement…) following the regulation. Supervise the registration of marketed product.

Work Experience: more than 3 years experience in Regulatory, prefer pharmaceutical MNC
MINIMUM BACKGROUND/ EXPERIENCE REQUIRED
CORE Skills Required:
Professional Skill
• Honest, careful, patient, highly responsible
• Persuasiveness
• Time management
• Good in working arrangement, teamwork
Language Skill: Vietnamese/ Tiếng Việt & English/Tiếng Anh
Computer Skill: MS office
Behavioral / Leadership Skill: Apply Abbott Capabilities Framework
MINIMUM EDUCATION REQUIRED
• Pharmacist/or Bachelor’s degree/or Medical Doctor

13 month salary & performance bonus

Premium Healthcare for personal & family

Training

Cập nhật gần nhất lúc: 2024-04-03 11:30:43