Posted:13 hours ago|
Platform:
Work from Office
Full Time
Other essential skills: LATAM/ GCC/ MENA/ SEA/AFRICA/ change control/ Art work checking Job description:
1) Complete understanding of requirements & regulations of ASEAN/
AFRICA/LATAM/ GCC/ MENA markets wrt New submissions, Re-
registration & Variations.
2) Prior experience of carrying out high quality CMC review of all kind
of technical documentation & Art-works,
3) Review and /or Compilation of country specific/ CTD/ACTD dossiers
for new submissions & renewal/ Variations submission .
4) Must be an Individual contributor + Good team player.
1) Collate, compile & author high quality CTD sections for M1, M2, M3,
M4 & M5.
2) Detailed review of technical documents required for Regulatory
submissions e.g. PVP/PVR/AMV/Stability report
Protocol/Specifications/ COAs/ BE study/ DMF etc.
3) Coordinate with Plant for required documents/ samples/ working
standards etc. through emails/ phone calls for smooth running of
Projects.
4) Utmost care is recommended to minimize the unwanted errors while
working with documents i.e. authoring & reviewing the data.
Edge Pharma Pvt. Ltd.,
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