The
Regulatory Affairs Assistant Manager
is responsible for planning, preparing, and monitoring dossiers for approval related to the registration, notification, and certification of local and imported products. This role involves managing BE projects, evaluating dossiers for GMP assessment, providing regulatory updates, and other projects. The Assistant Manager also ensures compliance with government regulatory requirements in Vietnam and participates in packaging design checks and barcode management.
Monitor and update product information on the Regulatory Affairs website.
Handle BE projects for assigned drugs including contact and consult with BE Centers (Ha Noi and HCM) to obtain prices and timelines, purchase comparator drugs for BE Testing in the Plant. Assist in data/information gathering and dossier compilation for BE Testing in BE Centers.
Consult involved internal and external entities on regulatory requirements to perform the assigned tasks and provide advice to related departments as needed.
Request, review, and prepare registration/ notification/ variation documents for drugs, cosmetics, and food supplements according to the plan.
Drug pricing registration.
Handle advertising tasks including review and/ or prepare documents for advertising and conferences, ensure compliance with regulations.
Monitor, provide, and manage barcodes for Vietnam.
Monitor and follow up on data/information gathering and dossier compilation for product registration and submission.
Participate in checking packaging design for registration and production.
Monitor the status of and prepare licenses/certificates and check/prepare documents for registration/certification, including Satisfaction of Drug Trading Condition certificate (SDTC), Pharmacist licenses, GMP, CoPP, FSC certificates.
Medical device registration.
Check reports to MOH/DAV/SOH for importation/exportation of raw materials, packaging materials, and finished medicinal products, manufacturing and market distribution of local medicines.
Other related licenses/certificates registration.
Handle projects and tasks assigned by line manager.
Plan registration activities based on new product line- up.
Assistant for RA&SC Director.
Check and prepare additional documents related to feedback on registration/notification/certification documents from health authorities.
