0 years
0 Lacs
Posted:1 week ago|
Platform:
On-site
Full Time
· Preparation of CTD/eCTD format drug master file and its submission to various regulatory authorities including USA, Europe, Canada, Australia, China, Japan, Korea, Brazil and ROW market
· Preparation of query response of drug substance for various and less regulated markets and customers.
· Preparation of applicant part and closed part for various authorities for different customers.
· Preparation of annual updates and amendment of drug master files US via ESG, ASMF via CESP, KDMF via MFDS Korea,
· Preparation and submission of CEP applications and responses to EDQM via CESP.
· Preparation of CEP LOA’s & LOA’s and declarations of various customers and authority.
· To collect and evaluate scientific data for assessment and prepare regulatory submission for authorities and customers.
Cadila Pharmaceuticals Limited
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