Regulatory Affairs Executive (Temp 6 month)

POSITION: REGULATORY AFFAIRS EXECUTIVE (TEMP 6 MONTH)
- Work location: Lot B3, Cong Nghiep 4 Str, Sai Dong B Industrila Park, Long Bien, Hanoi
- Report to: Head of Regulatory Affairs
MAIN DUTIES:
· Co- ordinate with AbbVie in Artwork Label Reviewing and Approval process.
· Closely follow up the status of application from the time of submission until getting approval.
· Support to Marketing Team on internal reviewing/ submiting/geting approval for brochures
· Prepare registration dosier, ensure that the drug registration dossiers submitted to the authorities on time with accurate information
· Evaluate and review registration dossiers for administration
· Support to Tender Team on submiting/following/geting approval of Brand Name Listing, EU GMP Listing,
· Communicate clearly with the DAV staff/experts and AbbVie RA on the query if any, based on the scientific of drug registration and regulations.
· Keep tracking of registration status, submissions, approval and registration timeline
· Support to Tender team by checking tender dossier requirement, fulfil the required information and providing available documents for tenders, clear up the tender document ‘s content.
· Understand and practice on time the updates in regulations/new guidelines/circulars by DAV
· Establish strong relationships with appropriate regulatory reviewing bodies efficiently to facilitate the smooth registration activity

Education & Qualification
Good relationship with the authorities related to registration tasks (Ministry of Health, Drug Administration of Vietnam)
Good knowledge and understanding of legal requirements related to product registration for pharmaceutical products
Bachelor’s Degree in Pharmacy
Working Experience
At least 5 years of managerial/specialist experience in Regulatory Affairs for the Pharmaceutical industry
Skills
Computer literacy
Good communication skills
Good command of English
Analytical skills
Problem- solving skills
Reporting skills
Other Specific Requirements
Honest
Careful
High sense of responsibility

Laptop, Chế độ bảo hiểm, Du Lịch, Chế độ thưởng, Chăm sóc sức khỏe, Đào tạo, Tăng lương

Cập nhật gần nhất lúc: 2024-11-08 21:15:02