7 years of strong experience in Pharmaceutical Regulatory Affairs and Clinical Trial Submissions.
- Proficient in Regulatory filings for New Drug Submissions, Subsequent New Drug Submissions, Biological Submissions, CMC notifications etc in various therapeutic areas.
- Worked on Clinical Trial submissions in different therapeutic areas like Oncology, Cardio-Vascular Systems, Respiratory, Rheumatology etc.
- Efficient management of projects entirely from submission till start-up activities
- Regulatory acumen at building efficient regulatory strategies
- Well acquainted with eCTD structure and submission processes as well as regulatory publishing processes.
- Well acquainted with ICH GCP principles and GMP/GDP practices.
- Well acquainted with Food and Drugs Act, NHP regulations, application processes and the organizational structure of Health Canada and US FDA as well as the review and approval processes
