Vraj Patel
Bloomington,Indiana
Summary
Quality and Regulatory Affairs professional with a Master’s in Regulatory Affairs from Northeastern University, experienced in risk management, quality systems, and regulatory compliance for drugs, biologics, and medical devices.
Overview
5
5
years of professional experience
Work History
Quality Engineer Co-op
CATALENT PHARMA SOLUTIONS
01.2024 - 04.2024
- Designed a system to continuously monitor key manufacturing processes, leading to a 20% reduction in errors and improved product safety and quality (SISPQ).
- Used BIOVIA DISCOVERANT to ensure accurate and compliant data reporting, increasing efficiency in data analysis and reducing errors.
- Conducted risk assessments for drug production, identifying key risks and reducing potential issues through targeted management plans.
- Developed plans to monitor the safety of auto-injector devices, ensuring compliance with industry standards (ISO 13485, EU 2017/745, 21 CFR 820).
- Produced detailed safety reports by tracking and analyzing product performance data.
- Streamlined the data request process, cutting processing time by 30% and improving compliance with best practices.
- Supported regulatory submissions by analyzing technical data, ensuring timely responses to regulatory authorities.
- Collaborated with production teams to update manufacturing records, reducing delays and improving efficiency in drug production.
Intern - Regulatory Affairs, Chemistry Manufacturing and Controls (CMC)
BRISTOL-MYERS SQUIBB
07.2023 - 09.2023
- Managed global regulatory submissions for post-approval changes in biologic drugs.
- Contributed to key sections of regulatory filings, ensuring compliance with industry standards.
- Drafted change control documents and assessments, supporting a 95% compliance rate for regulatory filings.
- Collaborated on risk assessments to ensure regulatory reports were accurate and complete.
- Assisted in submitting a regulatory change for a drug packaging system, maintaining product safety and compliance.
- Completed advanced training in quality management systems, improving my ability to handle non-conformities and CAPAs.
Business Analyst - Regulatory and Pharmaceutical Market Access
GLOBAL PRICING INNOVATION
01.2022 - 07.2022
- Optimized data processing methods, reducing time by 30% and increasing accuracy by 20%.
- Developed pricing strategies that increased profitability by 20% and enhanced customer satisfaction.
- Achieved a 35% automation target in data processing, improving team efficiency and decision-making.
Consultant, Medical Educator
IQVIA
09.2019 - 03.2021
- Led the implementation of stroke treatment protocols, reducing emergency response times by 26%.
- Increased participation in a global stroke initiative by 30% year-over-year.
- Trained and certified over 350 emergency medical personnel, improving patient outcomes by 28% and enhancing reporting accuracy by 25%.
Education
Master of Science, Regulatory Affairs - Drugs, Biologics and Medical Devices -
Northeastern University
Boston, Massachusetts12.2024
Bachelor of Pharmacy - Pharmaceutical Science -
University of Mumbai
Mumbai, India05.2019
Skills
- BIOVIA Discoverant Systems
- Product Lifecycle Management
- Risk Management
- MS Office
- Veeva Vault System
- Gap Analysis
- ECTD management
- Quality Management Systems (QMS)
- Project Management
- Lean Manufacturing Tools
Websites
Timeline
Quality Engineer Co-op
CATALENT PHARMA SOLUTIONS
01.2024 - 04.2024
Intern - Regulatory Affairs, Chemistry Manufacturing and Controls (CMC)
BRISTOL-MYERS SQUIBB
07.2023 - 09.2023
Business Analyst - Regulatory and Pharmaceutical Market Access
GLOBAL PRICING INNOVATION
01.2022 - 07.2022
Consultant, Medical Educator
IQVIA
09.2019 - 03.2021
Master of Science, Regulatory Affairs - Drugs, Biologics and Medical Devices -
Northeastern University
Bachelor of Pharmacy - Pharmaceutical Science -
University of Mumbai
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