Quality Assurance Regulatory Affairs

KANCHAN SONALI RAPALLI

+1-857-***-**** *.*************@*****.*** https://www.linkedin.com/in/kanchan-sonali-38938a207/ Boston, MA EDUCATION

Northeastern University. January 2023-Present

Masters in Regulatory Affairs, CGPA 3.9/4 Boston, MA Osmania University September 2016- September 2020

Bachelor of Pharmacy, GPA-7.8/10 Hyderabad, India

INTERNSHIP

Ventriflo September 2024-Present

Regulatory Affairs Intern Phlem, NH

• Investigated project requirements and collaborated with teams to prepare key questions for FDA pre-submission presentations. Established a 510(k) framework by identifying predicate devices and organizing documentation for compliance.

• Refined presentation materials based on internal feedback, enhancing clarity and ensuring alignment with regulatory expectations. Hippo Laboratories June 2019 -December 2019

Quality Assurance Intern Hyderabad, TG

• Performed thorough reviews of manufacturing batch records and QC test results for Cefixime, ensuring adherence to GMP standards, which increased compliance and reduced documentation errors by 15%.

• Drove accountability for quality assurance processes during CAPA investigations, identifying the top three causes of non-compliance within operations and establishing procedures to address these critical areas PROJECTS

Northeastern University June 2024-August 2024

Regulatory review project Boston, MA

• Developed detailed regulatory review documents for Sandoz's Omnitrope approval process under the {505(b)(2) FD&C Act}, influencing compliance standards and streamlining submission processes in investigational drug development frameworks.

• Analyzed and interpreted clinical trial data from 120 patients, comparing the efficacy of Faslodex to alternative hormonal therapies; generated insights that informed strategic planning for future breast cancer studies. Osmania University. December2019 -July 2020

Anti-Urolithiasis Activity Research Hyderabad, India

• Revised data from 15 experimental trials exploring the inhibitory effects of different concentrations of Vaccinium macrocarpon on calcium oxalate crystallization processes leading to enhanced understanding within nephrology studies.

• Analyzed crystallization kinetics of calcium oxalate in response to varying concentrations of Vaccinium macrocarpon; identified three optimal levels that reduced crystallization rates by over 20%, enhancing nephrology research outcomes. Comparative phytochemical screening of udrakalp churna

• Conducted comprehensive in vitro studies assessing the anti-inflammatory properties of five distinct marketed and in-house formulations of churan, leading to a published article in the Indo-American Journal of Pharmaceutical Research.

• Quantified active compounds in five distinct formulations by employing advanced analytical techniques, including HPLC and GCMS; findings contributed to a published article, enhancing the understanding of therapeutic effects for improved patient outcomes. CERTIFICATIONS & CONFERENCES

Regulatory Affairs training program -Dukes University October 2024

• Analyzed key regulations impacting FDA submissions and created detailed process maps that identified three critical bottlenecks; improved team readiness for actual submissions through clear visual guides used across departments. TSCS-NICE2016 September 2016

• Volunteered at prominent industry conferences like TSCS-NICE2016 to compile actionable takeaways for implementation back home, developing four key recommendations directly impacting local practice efficiency measures. SKILLS

• Regulatory Affairs: -Regulatory Document Preparation, FDA Submissions, 510(k) Framework, ISO 13485 Compliance, International Regulatory Compliance, Risk Assessment, Regulatory Strategy and Planning, eCTD, IND, CE Marking, PMA, Product Life Cycle, Timeline Development, Regulatory Submissions, Adverse Event Reporting, Export Compliance, Greater China Regulatory Strategy, Request Management, Audits, Preventive Actions, Change Orders, Supports.

• Quality Assurance: -GMP Compliance Standards Adherence, CAPA Investigations and Protocols, Batch Record Review Processes, Quality Testing Protocols and Techniques, Documentation Systems Management, Risk Management Techniques, Change Control, HACCP, Hazard Analysis, Materials Management, Control System Validation & Implementation and Optimization, Maintenance, Quality System, Supplier Audits.

• Research and development: -Clinical Trial Efficacy Comparison, Investigational Drug Development Frameworks, Regulatory Review Document Development, Data Interpretation Techniques, Strategic Planning for Clinical Studies, Audits.

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