Regulatory Affairs

Địa điểm làm việc: 111A Pasteur, District 1, HCMC

POSITION SUMMARY

• To manage company licenses registration/renewal for import and transport permits with regards to all Sales Departments with local authorities to import successfully
• Provide up to date information regarding all laws and regulation relates to company business operations in order to make the company comply with those relevant laws/regulations.
• Monitor related new laws and regulations to support all Sales Department units of Company and give guidelines to Department Managers to avoid business risk.
• To be a member of ISO committee to prepare for manual, procedures, work instruction
• To control business operation compliance

MAJOR RESPONSIBILITIES

• Responsible for Country logistics compliance mainly are:
• Country product HS code
• Country product license/ permit including other local requirements (import, export, trade, transport, store, transform of packaging, tax benefit)
• Management of change in local & international regulations relating to HS code, import, export, trade, transport, store, transform of packaging, tax benefit.
• Communication of update/change in relating to regulatory
• Responsible for implement and in charge of New Product Creation process
• Act as process owner and responsible for ensuring all regulatory process have carry out correctly (by internal or service provider)
• In charge of regulatory service provider selection, evaluation, approve process/ procedure, approve job completion.
• Manage regulatory filing, record retention per company and local regulation requirement and effectively communicate to team.
• Lead country regulatory data base initiatives and ensure status are update.
• Work hand in hand with logistics, DMs, BLHs to maintain process effectiveness and competitive advantage
• Maintain regulatory affair relation both in and external
• In charge of internal & external regulatory audit and communicate to CM, BLH, RSCM

REGULATIONS

• Provide management team with up to date information regarding all laws and regulations affecting registration and company business
• Provide opinion / consulting basing on research of relevant rules and regulations in order to make the company comply with relevant laws
• Review relevant reports for correctness prior to authorization of the management
• Monitor company business activities to be compliance with laws & regulations
• Communicate in term of the amendment for updated information of license i.e. new business unit and new distribution channel

COMPANY LICENSE
- Responsible for annual renewal of licenses and any changes such as license holder, warehouse, pharmacist etc.

Import and Transport Permit
- Responsible for Import and Transport Permits in order to comply with all laws and/or legal procedures