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Regulatory & Legal Specialist

Salary undisclosed

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  • Conduct analysis and review related to documents required for product registration
  • Conduct registration document requests to the Principal
  • Register products to the Ministry of Health, BPOM, SNI, Halal, etc,.
  • Conduct follow up and monitoring of the product registration process
  • Conduct consultation and negotiation related to the product registration process
  • Compile Product Information Documents
  • Directly liaise with external parties, government institutions, or any other relevant regulators
  • Handling and taking responsibility for the contract management system and ensuring legal documentation is well-maintained
  • Develop and implement policies and procedures to enhance legal processes and compliance
  • Mastering legal regulations regarding contracts and all related legal documents with internal, external ; vendor, client, consultants, and other third parties related such as drafting SPK.
  • Process and manage all the issues

Requirment :

  • Bachelor of Pharmacy/Pharmacist (preferred)/Biomedical/Science / Law with a minimum cumulative GPA of 3.00 from a reputable university
  • Minimum 3 years of experience in Regulatory Officer, Medical Devices regulation, Law, or similiar
  • Fluent in English both spoken and written
  • Able to work under pressure, proactive, and fast learner
  • Have good knowledge of government regulations, such as BPOM, SNI, Halal, GMP (Good Manufacturing Practices) & Government Regulation
  • Conduct analysis and review related to documents required for product registration
  • Join ASAP