- 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)