Abbott

Actively Hiring

Regulatory Affairs Specialist

Thuan An, Vietnam

Full time

Role Overview

Handle process of registration of new products, maintenance of all approved products in Vietnam and operate marketed products according to local regulations.

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Key Responsibilities

Reviews and compiles registration dossier for prompt renewal/initial/ variation registration
Ensures availability of updated registration documents/samples
Fast requisition of dossier and check requests
Initiates/monitors/updates Regulatory Report in timely manner
Register and compiles registration dossier for promotional material
Ensures all promotional materials are lawfully compliance
Be aware of coming new regulation/change that impact to regulatory or business
Inform head of Department/contacts all change and upcoming new regulations

Requirements & Eligibility

Bachelor of Pharmacy
Strong knowledge of Vietnamese pharmaceutical regulations
Minimum 5 years of experience in Regulatory Affairs, preferably with a local pharmaceutical company
Experience in R&D or QA or QC will be an added advantage
Language skills: Vietnamese, English
Computer skills: MS Office

Required Skills & Tech

Regulatory AffairsRegulatory CompliancePharmaceutical RegulationsMS Office