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Regulatory Affairs Specialist - CMC (USFDA) vueverse.

7.0 - 11.0 years

0 Lacs

hyderabad, telangana

On-site

As a Regulatory Affairs Manager specializing in CMC, you will be responsible for leading and managing all CMC regulatory activities related to USFDA submissions, specifically focusing on ANDA preparation, review, and filing. Your role will involve overseeing the compilation and timely submission of Annual Reports, amendments, and responses to deficiencies. You will collaborate with cross-functional teams such as Quality Assurance, Production, and R&D to gather the necessary documentation and data required for regulatory submissions. A significant aspect of your responsibilities will include reviewing and ensuring compliance of Batch Manufacturing Records (BMR), process validation documents, ...

Posted 2 months ago

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