Year of professional experience
JASHWANTHI RAAVI
Summary
Detail-oriented regulatory specialist with a solid background in regulatory affairs and clinical research experience. Demonstrated expertise in ensuring compliance with international standards, including FDA (505(b)(2), PMA, 510(k)), EU MDR, and PMDA. Skilled in conducting risk assessments, preparing submissions, and developing effective regulatory strategies for international markets. Proficient in designing and analyzing clinical studies, collaborating across functional boundaries to achieve project goals. Proven track record of streamlining regulatory processes and ensuring product safety, particularly in the field of medications and medical equipment. Experienced in handling human factors, labeling, and usability studies to facilitate successful product approvals. Well-versed in ISO standards to maintain quality and regulatory compliance.
Overview
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Certification
Work History
Regulatory Affairs Intern
Sem Presto Inc
09.2024 - Current
- Expertise in 505(b)(2) submissions and evaluation of alternate pathways (505(b)(1), PMA, 510(k))
- Conducted research on predicate devices and surveyed historical filings to inform regulatory strategies
- Assessed pros and cons of 505(b)(2) regulatory submissions for optimal product approval strategy
- Developed outlines for product testing (shelf-life, performance, reliability) and manufacturing processes
- Applied recognized international standards (e.g., ISO 11608) to regulatory submissions and testing protocols
- Interpreted and implemented FDA guidelines for auto-injectors (2013, 2020, to align product development
- Managed drug (epinephrine) and device (auto-injector) predicate analysis to refine submission strategy
- Conducted human factors and usability studies, aligning with FDA guidance for product safety and efficacy
- Developed labeling strategies and ensured regulatory compliance for software- based medical devices
- Performed top-level system hazard analysis and risk assessments in compliance with ISO 14971
- Experienced with regulatory requirements for EU (MDR, CE marking) and Japan (PMDA)
- Prepared for FDA pre-submission meetings, including question development and documentation.
Project Intern
KVSR Siddhartha College of Pharmaceutical Sciences
03.2022 - 08.2022
- Conducted preclinical research on pharmaceutical excipient, contributing to the understanding of drug safety and efficacy
- Demonstrated strong analytical and problem-solving skills by identifying key excipient impacting drug safety, leading to a 20% improvement in hepatoprotective properties
- Gained proficiency in research methodologies and scientific documentation, including data analysis and interpretation.
- Delivered high-quality presentations on project updates and findings to senior management and stakeholders.
Student Intern
Accurate Labs, KVSR SCOPS
09.2021 - 02.2022
- Pharmaceutical Sciences
- Enhanced laboratory efficiency by 15% through proficiency in HPLC instrumentation and optimized sample analysis procedures
- Contributed to research projects by conducting over 50 sample analyses, ensuring strict adherence to regulatory standards
- Strengthened understanding of regulatory compliance in a laboratory setting through hands-on experience in quality control procedures.
- Developed time-management skills through balancing multiple assignments while consistently meeting deadlines during the internship period.
- Collected, arranged, and input information into database system.
- Generated reports detailing findings and recommendations.
Education
Master of Science - Regulatory Affairs
Northeastern University
Boston, MA12-2024
Bachelor of Science - Pharmacy
Krishna University
08-2022
Skills
- MS Office
- Microsoft Excel
- CTD
- eCTD
- IRB applications
- GLP and GCP Compliance
- Regulatory Submissions
- Regulatory filings
- Regulatory Guidelines
- Regulatory Compliance
- International Regulatory Affairs
- Medical Device Regulation (MDR)
- Post-market Surveillance
- Audits & inspections
- Regulatory strategy Development
- Risk analysis
- QMS
- Clinical Study Design
- Clinical Data Management
- Clinical Trials Protocols
- Clinical Trials Oversight
- Biomedical Product development
- Drug discovery & Development
- Medical Device Development
- Bio-Safety
- Project Management
- Strong communication skills
- Organization Skills
- Adaptability
- Agile mindset
- Analytical Skills
- Problem-solving
- Strategic Thinking
- identifying issues
- Market Research
- Product Lifecycle Management
- Cooperative
- Active listening
- SOPs
- Document Management
- FDA regulations
- GMP Knowledge
- Teamwork and Collaboration
- ISO Standards
- Policy analysis
- Validation Protocols
- EMA Regulations
- Labeling and Packaging
References
- Jaya Bharath Chandra Gutta, MS; Baystate health / jay.gutta@baystatehealth.org
- Arpit Sharma, MS, RAC; Takeda / ar.sharma@northeastern.edu
Certification
- Project management foundations, LinkedIn - October 2024
- Project management: Health Care, LinkedIn - October 2024
- Designing a Clinical trial, RAPS - September 2024
- Audits and Inspections, RAPS - September 2024
- Building an efficient literature review process, RAPS - September 2024
- Research & writing using AI, LinkedIn - June 2024
Languages
English
Native or Bilingual
Telugu
Native or Bilingual
Hindi
Limited Working
Timeline
Regulatory Affairs Intern
Sem Presto Inc
09.2024 - Current
Project Intern
KVSR Siddhartha College of Pharmaceutical Sciences
03.2022 - 08.2022
Student Intern
Accurate Labs, KVSR SCOPS
09.2021 - 02.2022
Master of Science - Regulatory Affairs
Northeastern University
Bachelor of Science - Pharmacy
Krishna University