Regulatory Affairs Executive (Temp 6 month)

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.