Regulatory Affairs Compliance Althera Laboratories India Pvt Ltd, Bangaore

5.0 - 8.0 years

7 - 15 Lacs

Bengaluru

Work from Office

Reporting to Sr. Director - Regulatory Affairs Experience required: 5-8 Years Education: B. Pharm / M. Pharm Department: Regulatory Affairs Key Responsibilities: Prepare the status of all documents related to submission. Compile and review Regulatory submission documents required in line with the relevant guidelines. Coordinate with all stakeholders of the manufacturing plant for the collection of documents. Evaluation of change control: evaluate all post-approval changes. Review of specifications (API, Intermediate, FP, and Shelf life) executed BMRs, BPRs, COA, Method transfer report, Method verification, Analytical chromatograms intended for regulated or non-regulated market submission. Ge...

Posted 3 months ago

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