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Accountability Statement/Summary

• To manage the regulatory activities of A. Menarini - Thailand effectively.
• To provide technical support to all principals and new businesses as required.
• To update management on Regulatory policy changes.

Responsibilities include but not limited to:

• Product Registration;
  • Submitting documents and follow up until obtaining approval for registration of non-NCE, medical devices, cosmetic products and food supplements.
  • Submitting required documents for GMP clearance, variation and regulatory compliance to the FDA.
  • Submitting documents for amendment and renewal of approved licenses.
  • Providing information to principals as requested.
• Documentation;
  • Reviewing the registration documents, approved licenses and related documents such as certificates of analysis and etc.
  • Submitting and follow up until obtaining approval for simple promotional materials.
  • Submitting monthly, quarterly, half-year and annual importation and sales reports to FDA.
  • Submitting restricted product reports (narcotic/ psychotropic/ new drugs) to the FDA.
  • Preparing registration status reports for principals monthly.
  • Providing additional documents for products clearance, if required.
  • Providing additional documents for hospital biding/ tender, if required.
• Pharmacovigilance Activities:
  • Comply with local FDA regulatory requirements for reporting adverse drug reactions.
  • Comply with each principal’s Pharmacovigilance SOP/Agreement.
  • Collate collected adverse event during new products safety monitoring program (SMP) period.

Submit for unconditional approval (SMP release) of new product

• Others;
  • Coordinating with other departments related to registration, amendment of approved licenses, promotion materials, and advertisement permission.
  • Coordinating with marketing department and principal related to quality assurance of product.
  • Verifying labels and packaging materials according to the FDA requirements for imported product.
  • Verifying promotion materials according to the FDA requirements and approval.
  • Checking and translating Certificates of Analysis.