Hello there! I'm a seasoned Regulatory Affairs and Compliance enthusiast with a knack for unraveling the intricacies of FDA, EU, and global regulations. My journey has been a testament to meticulous documentation, compliance, and leadership. I find joy in orchestrating seamless teamwork and taming complex projects. Certified in medical device regulatory requirements, I'm deeply committed to shaping compliance landscapes. In my role as a clinical research associate, I worked with senior operation team members to ensure compliance with applicable regulations and SOPs, and to distribute reports and data to internal and external stakeholders.Let's connect, chat, and explore how we can make a difference together.
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Regulatory Affairs Intern Capstone ProjectProject Insulin Sep 2023 - Dec 2023Boston, Massachusetts, United States -
Regulatory Affairs Coordinator In Clinical ResearchWissen Infotech Jan 2021 - Nov 2021Pune, Maharashtra, India• Reviewed, processed, and classified safety data from multiple sources, distributing patient safety reports to internal and external stakeholders, achieving 100% compliance with regulations and guidelines. Provided vital administrative support.• Managed comprehensive data tasks, including collection, entry, and review, resulting in a 98% accuracy rate. Conducted analysis, report writing, and maintained protocol revisions for product lines, ensuring strict adherence to SOPs.• Significantly improved data integrity and compliance by streamlining DSUR review processes, resulting in a 20% reduction in review time.• Led organizing global team meetings, resulting in a 30% increase in meeting efficiency, and supervised audits alongside investigators, contributing to a 15% improvement in business processes.• Effectively oversaw a regulatory QA database, expediting approvals and reducing approval times by 25%. This improved compliance procedures, resulting in a 98% compliance rate, enhanced data precision, and facilitated the resolution of regulatory issues. Additionally, managed research coordination responsibilities with a 100% success rate.• Developed and maintained a comprehensive documentation archive, streamlining access to critical information and reducing retrieval time by 30%.• Conducted regular quality control audits, resulting in a 95% compliance rate and the identification of areas for improvement, leading to enhanced data quality.
Prasanna S Education Details
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Regulatory Affairs -
Ndmvp College Of Pharmacy,NashikPharmaceutics
Frequently Asked Questions about Prasanna S
What is Prasanna S's role at the current company?
Prasanna S's current role is Seeking full time opportunities in Regulatory Affairs | MS' 23 | Graduation-Dec 2023 | Eager to Drive Compliance and Success in Full-Time Roles.
What schools did Prasanna S attend?
Prasanna S attended Northeastern University, Ndmvp College Of Pharmacy,nashik, Government College Of Pharmacy, Karad.
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