Posted:11 hours ago|
Platform:
Work from Office
Full Time
Dossier Preparation in CTD/ACTD/Country Specific Formats
2. Re-registration and Renewal Application
3. Variation Application
4. Queries Handling
5. DMF Activity
6. Artwork Review (Carton/Foil/Label/Insert/Shipper)
7. Pack Insert Preparation as per Country Guideline
8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement.
9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Search Strategy, AMV, CDP, BE Study.
Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories.
Avantika Medex
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