Bioptimal International Pte Ltd – Intern, Regulatory Affairs

Job Description

• Assist the RA team for local regulatory matters such as HSA submission, SAP and Product Registration (APAC)
• Arrange documents for notarization and legalization
• Administrative support to the RA Team, eg: document delivery, raise invoice, etc.
• Assist in research work for CER preparation for all CCP products
  
  
• Singapore – Local regulatory support
  • Assist the RA team for local regulatory matters
    
    
• HSA submission
  • Free Sales Certificates
  • Responding to distributors or other parties’ request for free sales certificates
  • Renewal of product licenses
  • Application of Export Certificates
  • Assist in any other local regulatory matters, such as change notifications or communicating with HSA to clarify any issues.
    
    
• SAP
  • To understand how the company system in legal control of registered product before selling to market
  • Assist RA team for SAP required tasks (Raise PR and etc.)
  • Respond to other departments requests (e.g. Customer Service when shipment out are blocked)
    
    
• Product Registration (APAC)
  • Assist RA team’s regulatory projects
    • Providing required information and documents
  • Compile dossier for submission
    • To understand the various regulatory requirements
    • Liaising with distributors to understand their requests.
    • Compile documents, samples etc. required for submission, which involves interacting with the various departments and distributors.
    • Draft required documents such as letter of authorization or declaration
      
      
• Legalization of documents
  • Documents for use overseas will often require legalization.
  • To familiarize with the legalization procedures and the varying requirements from the various Embassies
  • Arranging to send documents for legalization
  • Manage the payment for legalization
    
    
• Administrative support to the RA Team
  • Taking of minutes
  • Organization of documents.
  • Handling shipment of documents sent locally and overseas
  • Ad-hoc project on QMS documentation management and data analysis for audit preparation.

Requirements

• Pursuing Bachelor degree on Mechanical / Chemical / Biomedical Engineering, Pharmaceutical, Biological / Chemistry Sciences.