Scope of Responsibilities
Line Manager:
Line 3 : Country Manager
Line 1 : Legal Supervisor
Line 2 : Operation Manager
Main duty :
Co- ordinate and main handling for inspections/ post- inspection related to company’s regulatory activités.
Following- up and working closely with Brands to keep updating all changes related to products for taking needful action on time.
changing, updating information products), advertising contents/ marketing materials registration, promotion registration, …
In charge of all regulatory tasks such as registration product notification (include register new,
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
Responsible for preparing and submitting dossiers for other activities related to products’ regulatory (i.e. sub- label, barcode, approval for contents of advertisements, promotion, …).
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, …
Build relationships with MOH and governmental organizations who might help for a better process and support.
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, …).
In charge of preparing dossiers and applying for all needful license related to company’s
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.
Coordinate with other departments to provide them with the products’ documentation when necessary.
Researching the new/ needful regulation relating to business investment plans as assigned.
regulatory activities such as license for circulation of medical equipment, license to qualify for medical equipment business, … to distribute company products into the market.
Coordinate with importer and Brands to update any news/ changes related to products after importation.
Monitoring & updating new regulations and its impact on company activities. Ensure all products marketed in Vietnam complies with applicable laws.
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.
Reporting and other tasks:
Other tasks assigned by line managers.
Providing line managers a full report of regulatory matters and tasks.
Preparing periodical and/ or ad- hoc reports to competent authorities
Coordinating and main handling with state agencies to serve inspections/ post- inspections related to the company regulatory activities.
