Regulatory Affairs-CMC- Queries Aurobindo Pharma

1.0 - 3.0 years

1 - 3 Lacs

Hyderabad, Telangana, India

On-site

Preparation, review and compilation of assigned ANDA/NDA [505 b (2)]/projects for filing and knowledge of eCTD, Module 2 and 3. Hands on experience in reviewing CMC documents of Solid and Liquid Oral Dosage forms. Preparation, review and compilation of Supplements and Amendments. Review of Pharmaceutical Development Reports Review of manufacturing documents like batch manufacturing records, batch packaging records, yield and reconciliation, manufacturing summaries, hold time study reports, master formula cards, master packaging cards etc. Review of analytical documents like specifications, test procedures, method equivalency reports, method validation/verification reports and method transfer reports, dissolution protocols (multi point, multimedia and alcohol dose dumping etc), stability protocols and stability data

Posted 2 weeks ago

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