Back to search:Regulatory Affair / Jakarta (central)
  • Notarization Document
  • Legalization document in ministry of law and Human Rights/apostille
  • Legalization document in ministry of Foreign Affairs
  • Legalization document in Embassy
  • Heavy metal/Other test in external lab
  • BPOM submission : GMP export, CPP, CFS, Health Certificate
  • Arrange DHL shipment to other country
  • Maintain Veeva RIMS updated (Dossier, Dossier Archive, Reg Objective, Artworks, Registrations)
  • Tech. transfer support in Veeva vault RIMS (Dossier binder creation and document upload)
  • Tech transfer support in GAP analysis (excel file and work file), dossier review, and comment recap
  • Advertisements submission to BPOM
  • Drafting/submission of renewal/variation registration to BPOM
  • Validation excipient and supplier in New Aero
  • Help review dossiers and artworks
  • Help to make a form excel budget LCM AMA
  • Help to create PO in coupa
  • Help BPOM payment settlement
  • Create and maintain LRA database updated
  • Consultation to BPOM/MoH and follow up BPOM
  • Proceed applicant declaration to PTMI
  • Help LRA to review and/or assess regulatory matters

Requirement :

  • Bachelore Degree from Pharmacy
  • Experience with BPOM Requlation and Law
  • Strong Communication skills and attention to detail
  • Analytical Skill
  • Intermediate English
  • Advance in MS. Office (Word, Excel, Pivot & Power point for presentation)