- 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 new 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.