The University of Sydney Vietnam Institute

Mô tả Công việc

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:

· Evaluate and review registration dossiers for administration

· Prepare registration dosier, ensure that the drug registration dossiers submitted to the authorities on time with accurate information

· Closely follow up the status of application from the time of submission until getting approval.

· 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

· Establish strong relationships with appropriate regulatory reviewing bodies efficiently to facilitate the smooth registration activity

· Understand and practice on time the updates in regulations/new guidelines/circulars by DAV

· Co-ordinate with AbbVie in Artwork Label Reviewing and Approval process.

· Support to Marketing Team on internal reviewing/ submiting/geting approval for brochures

· Support to Tender Team on submiting/following/geting approval of Brand Name Listing, EU GMP Listing,

· 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.

Yêu Cầu Công Việc

1. Education & Qualification
Bachelor’s Degree in Pharmacy
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
2. Working Experience
At least 5 years of managerial/specialist experience in Regulatory Affairs for the Pharmaceutical industry
3. Skills
Good command of English
Computer literacy
Good communication skills
Reporting skills
Problem-solving skills
Analytical skills
4. Other Specific Requirements
Careful
Honest
High sense of responsibility