Drug Regulatory Affairs Officer

Indonesia, Jakarta

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Drug Regulatory Affairs Officer is responsible for the regulatory compliance documents and to ensure Roche products are approved in timely and professional manner. Reporting to Drug Regulatory Affairs Manager, you will be responsible for:  

  • Prepare and complete the required documents (such as registration documents, Certificate of Pharmaceutical Product (CPP), Good Manufacturing Practice (GMP), Manufacturing License, etc.) for registration submission purpose to local Head Authority in collaboration with both local and Global Function (Pharma Development Regulatory (PDR), Pharma Technical Regulatory  (PTR), International Product Partners (IPP)
  • Conduct preliminary review for registration artwork and check commercial artwork whether it is already comply with BPOM approval
  • Update the registration database and status (internal database, Global Product Regulatory System (GPRS)) in a regular basis
  • Manage incoming and outgoing communications letter from and to external parties related with registration
  • Report all of update registration process every month regularly
  • Liaise with BPOM for the ongoing review products to ensure on-time approvals is obtained

You have a Pharmacy/Apothecary degree and graduate from reputable university. Furthermore you have the following skills and qualifications:

  • Has a solid understanding of BPOM regulations and have 0-3 years experience in regulatory field    
  • Able to interpret regulatory requirements and guidelines
  • Show excellent communication, inter-personal skills, and personal influence
  • Has effective time management skill and able to set priority in task planning
  • Able to converse and write in English and computer literacy