Executive - Regulatory Affairs (API) Cadila Pharmaceuticals Limited

3.0 - 7.0 years

0 Lacs

gujarat

On-site

As a Regulatory Affairs Specialist, you will be responsible for the following tasks: 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. This includes ensuring compliance with the specific requirements of each regulatory body. Handling the preparation of query responses for drug substances in both highly regulated and less regulated markets, catering to the needs of diverse customers. Creating applicant parts and closed parts for submission to different regulatory authorities on behalf of various clients. Managing the annual updates and amendments of drug ma...

Posted 1 month ago

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