Karan Kungwani
Canada
Summary
Aspiring Regulatory Affairs Associate with a strong foundation in pharmacy and regulatory affairs. Skilled in database management, regulatory submissions, and industry regulations. Able to optimize approval processes through strategic planning and collaboration. Committed to ensuring successful market entry and enhanced patient safety. Dedicated to planning and executing regulatory submissions with a sharp focus on industry regulations and quality system management.
Overview
4
4
years of professional experience
Work History
Pharmacy Associate
Health Care Mart
01.2023 - Current
- Proficient in compiling and delivering daily patient reports to healthcare professionals to support accurate and efficient treatment decisions
- Maintained and Managed databases to ensure accurate tracking, organization, and accessibility of critical information for patient safety
- Streamline prescription filling process, reducing wait times and improving client satisfaction
- Implement inventory management system to minimize stock-outs
Pharmacy Associate
Bloordale Pharmacy
01.2022 - Current
- Maintained accurate records of medication dispensation and patient information, supporting compliance with regulatory standards and improving process efficiency
- Educated patients on proper medication usage and potential side effects, contributing to improved patient outcomes and adherence to treatment regimens
- Worked alongside pharmacists and healthcare providers to ensure medications were dispensed in line with legal and regulatory guidelines
- Maintained comprehensive records of medication dispensation and patient data, supporting regulatory compliance and internal auditing
Quality Assurance Associate
Aan Pharmaceuticals
01.2021 - 04.2021
- Shadowed pharmacovigilance team to learn about their daily tasks and compliance procedures
- Conducted quality analyses on diverse products, applying rigorous methodologies to ensure compliance with industry standards and regulatory requirements
- Meticulously executed daily quality assurance checklists and reports, contributing to maintenance of high product standards
- Partnered with cross-functional teams to implement new quality assurance protocols, enhancing overall product safety and efficacy
- Consistently met quality targets while maintaining a keen eye for detail, contributing to company's reputation for excellence
Regulatory Affairs Team Member
Docusys
03.2023 - 08.2023
- Shaped detailed regulatory approval plan for Canadian-based medical device manufacturer for European market
- Researched most cost-effective and swift approval pathway and submitted to consultants
- Built enhanced approval process using UKCA and C.E
- Pathways for Medical device and Health care products regulatory agency (MHRA)
- Analyzed regulatory requirements, ensuring compliance across documentation processes
- Streamlined workflows, resulting in faster approvals and reduced errors
- Developed new strategies for regulatory submissions, improving efficiency and accuracy
- Implemented digital tools to enhance document management and tracking
- Meticulously reviewed regulatory documents, ensuring adherence to industry standards
- Maintained comprehensive records for audits and inspections
Education
Master of Science - Regulatory Affairs
Northeastern University
Toronto, ON08-2023
Bachelor of Science - Pharmacy
Gujarat Technological University
Vadodara (India)06-2021
Skills
Regulatory Submissions
e-CTDs
Regulatory approval planning
Project Management
Regulatory strategy
Quality System Management
CAPAs
Regulatory audits
Timeline
Regulatory Affairs Team Member
Docusys
03.2023 - 08.2023
Pharmacy Associate
Health Care Mart
01.2023 - Current
Pharmacy Associate
Bloordale Pharmacy
01.2022 - Current
Quality Assurance Associate
Aan Pharmaceuticals
01.2021 - 04.2021
Master of Science - Regulatory Affairs
Northeastern University
Bachelor of Science - Pharmacy
Gujarat Technological University
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