Ms. Belli obtained her Master of Science (MS) degree in Biotechnology and further received her certifications in Biochemical Regulatory Engineering and in Biotechnology Management at University of Maryland, Baltimore County in 2015. She has been working for 4+ years in regulatory affairs – starting as an intern at MedImmune and growing into a global Regulatory Project Manager at AstraZeneca.

During her tenure at AstraZeneca/MedImmune (2015-2019) she provided regulatory expertise, efficient project management and strong leadership to global regulatory execution and cross-functional teams, working flexibly across regions. She contributed to submission strategies, identification of submission risks and opportunities, whilst leading end-to-end delivery of regulatory projects. Meghashri was involved in driving global regulatory agency interactions in compliance with regional requirements and drug development plans.

Regulatory Project Management Expertise

• Original IND/CTA

• IND amendments
• CTA amendments
• DSUR
• DMF submission and maintenance

• Regulatory Agency Interactions

• FDA
• EMA
• NMPA
  • NDA/BLA

• FDA and EMA Inspection Readiness

• sNDA/sBLA planning and submission
• Annual Reports, PADER, PBRER
  • Regulatory Systems

• Submission Planning

• Document Management

• Formatting and Publishing
• Submission Tracking
• eTMF

 

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