Cadila Pharma

· Preparation and submission of new DMF as well as annual updates to global markets including US , EU, Japan, China and Korea 
· Preparation and submission of CEP applications and responses to EDQM via CESP.
· Preparation and submission of amendments to DMF for various regulatory authorities including less regulated market authorities.
· Preparation of responses on the queries raised by customers and regulatory authorities on drug master files.
· Collection and compilation of documents to prepare Regulatory submissions and customers.
· Preparation of applicant’s part for regulated markets and less regulated markets.
· Preparation and submission of LOA’s, CEP LOA’s and declarations for various customers and authorities.
· Preparation and submission of SPLs for US FDA authority.

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Skills Required

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