Gangadhar Palle
Assistant Manager @Aurobindo Pharma Ltd
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WORK HISTORY
Assistant Manager @Aurobindo Pharma Ltd
Hyderabad, IN
Tracking and monitoring the process of regulatory submissions2. Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers3. Review / approval of technical documents required for submissions4. Ensure adherence to deadlines and regulatory compliance of submissions to regulatory authorities5. working knowledge of electronic document and submission standards6. Competent Authority monitoring and regulatory intelligence7. ADRs to monitor tracking from various regulatory authority safety information.8. SOP development9. TC Meeting coordinating with global affiliates10. Safety Review meeting cordination globally and vendor managemnt
EDUCATION
National Institute of Pharmaceutical Education and Research (NIPER) ,SAS NAGAR , Mohali
Master's degree
KAKATIYA INSTITUTE OF TECHNOLOGY AND SCIENCE
Bachelor of Pharmacy - BPharm
ABOUT GANGADHAR PALLE
Aggregate report management and Regulatory intelligence//Literature search strategy
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