Summary
Overview
Work History
Education
Skills
Projects
Volunteer Experience
Timeline
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Ranga Sai Naga Ravali Mummidisetti

Toronto,ON

Summary

Regulatory Affairs professional with a strong foundation in Canadian regulations, compliance, and submission management. Extensive experience in preparing regulatory submissions (CTAs, NDSs, SNDSs), ensuring Health Canada compliance while collaborating with cross-functional teams to achieve rapid approvals and optimize labeling. Demonstrates strong problem-solving abilities, agile in navigating fast-paced environments, and attention to detail in managing multiple projects. Proactive in aligning innovative regulatory strategies with commercial objectives, integrating research and development (R&D) insights, and addressing market needs. Skilled in social media strategy, product release, and consumer advocacy, with strong written and oral communication to express feedback, collaborate effectively, and drive success in regulatory and sales-related initiatives.

Overview

4
4
years of professional experience

Work History

Project Lead

Ecomedic
01.2024 - 03.2024
  • Spearheaded theoretical investigations on sustainability regulations in California, Colorado, and Arizona hospitals, delivering strategic insights that empowered the sponsor's long-term planning and decision-making
  • Orchestrated the review of hospital emissions reporting formats and methodologies, equipping the sponsor with actionable intelligence to ensure compliance with evolving regulations
  • Optimized project outcomes through the implementation of risk assessment analyses, contributing to enhanced regulatory compliance and sustainability efforts
  • Led the development of technical specifications and regulatory solutions for sustainability challenges, ensuring alignment with project objectives.

Clinical Development Associate

Incozen Therapeutics Pvt Ltd
08.2021 - 09.2022
    • Managed electronic trial master files (eTMF) for 17+ oncology clinical studies, ensuring 100% compliance with ICH-GCP standards
    • Performed extensive data analysis and interpretation for a Phase 2, randomized, double-blind, placebo-controlled study of RP7214, a DHODH inhibitor in SARS-CoV-2 patients, identifying critical trends for protocol adjustments
    • Supported global teams in executing oncology-focused clinical trials, achieving a 95% on-time trial completion rate through meticulous tracking and monitoring
    • Led regulatory submissions for oncology trials, ensuring timely submissions to regulatory authorities and ethics committees (CA/EC)
    • Created and validated regulatory documentation, including SOPs, informed consent forms, and data validation reports, maintaining data integrity and compliance with international regulations.

Clinical Pharmacy Intern

Apollo Health City
08.2020 - 08.2021
  • Audited prescriptions across six medical departments, identifying and mitigating critical medication errors, leading to a 25% reduction in reporting inaccuracies
  • Coordinated adverse event documentation and reporting, streamlining compliance processes through cross-functional team collaboration and advanced data management systems
  • Initiated improvements in clinical reporting workflows, enhancing patient safety and ensuring timely submission of adverse event reports by leveraging adverse event reporting systems
  • Utilized interpersonal skills and problem-solving skills to ensure optimal communication between departments and improve patient care protocols
  • Coordinated adverse drug reaction (ADR) reporting for oncology patients, ensuring regulatory compliance and timely submissions.

Project Lead

Apollo Health City
10.2019 - 07.2020
    • Pioneered the development of clinical protocols, case report forms, and SOPs, leading to a more efficient and standardized approach to study operations
    • Conducted data analysis on hyponatremia cases from one hundred patients, identifying key trends and presenting actionable insights that influenced clinical treatment protocols
    • Effectively coordinated regulatory submissions and maintained communications with ethics committees, ensuring timely approvals and full compliance with ethical guidelines throughout the entire study lifecycle
    • Designed prototypes for patient case report forms and implemented regulatory solutions based on clinical and research needs.

Education

Master of Science - Regulatory Affairs -

Northeastern University
Toronto, ON
03.2024

Doctor of Pharmacy – PharmD D -

Sri Venkateshwara College of Pharmacy
Hyderabad, India
08.2021

Skills

  • Oncology Expertise
  • ICH-GCP Compliance
  • Regulatory Submissions (eCTD, CA/EC)
  • SNDSs & NDSs Preparation
  • CTAs
  • ADR Reporting
  • Clinical Trial Management
  • Canadian Food and Drug Regulations
  • Data Analysis and Validation
  • Submission Management
  • MS Office (Word, Excel, PowerPoint)
  • Study Start-Up
  • Communication Skills
  • Cross-functional Team Collaboration
  • Document Management
  • Risk Assessment and Mitigation
  • Veeva Vault
  • Meeting Coordination and Minutes
  • Health Canada Guidelines Compliance

Projects

PMA Submission for Class III Medical Devices Biologics License Application Preparation of Protocol and Informed Consent Medical Device Recalls, IRB Preparation of Warning Letters and Enforcement Letters Serious Adverse Event Reporting

Volunteer Experience

  • Facilitated national TB awareness conference, addressing public health issues through leadership in educational workshops.
  • Created COVID-19 educational youtube videos, highlighting innovation in guiding public health practices during the pandemic.
  • Led medical camps and workshops in underserved communities, applying process improvement and time management to healthcare services.

Timeline

Project Lead

Ecomedic
01.2024 - 03.2024

Clinical Development Associate

Incozen Therapeutics Pvt Ltd
08.2021 - 09.2022

Clinical Pharmacy Intern

Apollo Health City
08.2020 - 08.2021

Project Lead

Apollo Health City
10.2019 - 07.2020

Master of Science - Regulatory Affairs -

Northeastern University

Doctor of Pharmacy – PharmD D -

Sri Venkateshwara College of Pharmacy

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Ranga Sai Naga Ravali Mummidisetti