Complete understanding of requirement and regulation of ROW/ LATAM/African countries/MENA/ASEAN markets wrt current submission, registration and variation.
Review and/ compilation of country specific/Preparation of dossier in CTD / ACTD for current submission/ variation submission.
Prior experience of carrying out hight quality CMC Review documents of technical documents require for registration i.e., BMR, Process validation, Method validation, registration documents etc.
Coordinate for Artwork preparing.
Draft confirmation of licenses - COPP, FSC, PP etc
Knowledge and understanding of ICH guidelines.
Coordinating for samples and documents & working standard.
Coordination with Advocate for Trade mark registration & record.
Tender documents compilation.
DGFT, Pharmexcil, FSSAI, RCMC application.
Plant visits intermittently if necessary.
GSTIN generation & recording of details.