Scope of Responsibilities
Line Manager:
Line 2 : Operation Manager
Line 3 : Country Manager
Line 1 : Legal Supervisor
Main duty :
In charge of all regulatory tasks such as registration product notification (include register new,
Co- ordinate and main handling for inspections/ post- inspection related to company’s regulatory activités.
changing, updating information products), advertising contents/ marketing materials registration, promotion registration, …
Following- up and working closely with Brands to keep updating all changes related to products for taking needful action on time.
Handle on license for circulation of medical equipment, license to qualify for medical equipment business and other needful licenses related to the company&039;s regulatory activities.
Main tasks :
Regulatory
regulatory activities such as license for circulation of medical equipment, license to qualify for medical equipment business, … to distribute company products into the market.
Researching the new/ needful regulation relating to business investment plans as assigned.
In charge of preparing dossiers and applying for all needful license related to company’s
Coordinate with importer and Brands to update any news/ changes related to products after importation.
Responsible for databases, processes, and systems to manage and maintain all regulatory documents needed (PIF dossiers, LOA, CFS, trademark, advertising registration, sub- label, barcode, …) for regulatory compliance.
Strictly following- up and updating with Brands for all new changes/ updating relating to products and taking needful action steps with authorities & internal team on time.
Build relationships with MOH and governmental organizations who might help for a better process and support.
Responsible for preparing and submitting dossiers for other activities related to products’ regulatory (i.e. sub- label, barcode, approval for contents of advertisements, promotion, …).
In charge of preparing dossiers for company products, including but not limited to products, medical devices and other products that company distributes registration, product declaration, modification, notification, ... and submitting to competent authorities (MOH, DA, …).
Coordinate with other departments to provide them with the products’ documentation when necessary.
Preparing, drafting the official letter, announcement to customers/ partners/ e- commerce platforms/ so- commerce on any changes on products such as main label, packaging, barcode, …
Monitoring & updating new regulations and its impact on company activities. Ensure all products marketed in Vietnam complies with applicable laws.
Reporting and other tasks:
Coordinating and main handling with state agencies to serve inspections/ post- inspections related to the company regulatory activities.
Preparing periodical and/ or ad- hoc reports to competent authorities
Providing line managers a full report of regulatory matters and tasks.
Other tasks assigned by line managers.
