Regulatory Affairs- CMC - SPD- US market

Job Description

Key Accountabilities Process/ Operational: 1. Basic knowledge for Review of Pharmaceutical Development Report. 2. Basic knowledge / hands on experience of review of manufacturing documents like batch formula, batch manufacturing records, batch packaging records, yield and reconciliation, manufacturing summaries, in-process controls data, etc. 3. Basic knowledge / hands on experience of review of analytical documents like specifications, test procedures, method equivalency reports, method validation/verification reports and method transfer reports, dissolution protocols, stability protocols, extractable & leachable study reports, etc. 4. Basic knowledge / hands on experience for preparation, review and compilation of assigned ANDAs for submission. 5. Basic knowledge / hands on experience for preparation, review and compilation of Annual Reports (ANDAs/NDAs). Strategic: 1. Basic knowledge of ICH guidelines, FDA guidelines. 2. Knowledge of CTD modules 1,2 and 3.