? Should be well versed with Regulatory Guidelines of South East Asia, Africa, Middle East, LATAM, CIS Countries (ROW Market)
? Knowledge of Preparation ,compilation & review of CTD , ACTD & ECTD Dossiers.
? Should be well versed in Handling customers & MOH query with respect to technical documentation (Stability Data, GMP, FSC, DMF etc.)
? Well versed in IP /BP /USP pharmacopeia.
? Should have a knowledge of applications of product permission , FSC, COPP
? Should have knowledge of Loan License & P2P.
? Artwork preparation as per respective countries guideline and Artwork checking.
? Dispatching Sample for registration.
? Keeping the record of registration status of all countries.
? Should be aware about preparation of tender bids.
? Inter Department coordination with Export / PPIC / Purchase / Artwork/ QA /QC / R& D/ Production & other related Departments.
📌 Regulatory Affairs Mumbai
🏢 Important Group
📍 Mumbai
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