HAMSA M SRINIVASA

Graduated in Pharmaceutical Regulatory Affairs and Quality Operations with a strong background on drug and medical device regulations in Canada.

Understanding on ICH Guidelines, USFDA submissions, EU submissions.

Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Adaptive, Self-motivated with strong interpersonal skills. Capable of conveying ideas and thoughts precisely. Strong hold on MS Office Suite - Word, Excel, PowerPoint, Outlook. Basic knowledge on Adobe Illustrator.

• Citi Program Health Canada Division 5 - Drugs for Clinical Trials Involving Human Subjects.
• Citi Program ICH – Good Clinical Practice – Canada.
• Govt of Canada - Medical Device Establishment Licensing and Post-market Regulation.