Tushar Patel
Ajax,Ontario
Summary
To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities.
Well-organized and diligent Regulatory Affairs Specialist adept at coordinating and tracking regulatory-related actions. Highly successful at keeping on top of changes in requirements to maintain flawless compliance. Offering 1 years' experience in Regulatory Affairs and looking for a challenging new role. Hardworking and passionate job seeker with strong organizational skills eager to secure entry-level Regulatory Affairs Intern or Regulatory Affairs Associate/ Specialist position. Ready to help team achieve company goals.
Overview
3
3
years of professional experience
Work History
Regulatory Affairs Intern
Lupos Biotechnology Company
04.2022 - Current
- Worked with governance committees to make and evaluate plans.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Prepared and maintained document inventory for core dossier preparation in collaboration with Job title.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
- Prepared and submitted regulatory file applications and supporting documentation.
- Received, researched and resolved consumer inquiries.
- Provided pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
Pharmacy Assistant
Rexall
11.2021 - 11.2022
- Greeted customers and responded to questions with friendly, knowledgeable assistance.
- Answered telephones and provided information about order status, store hours and pharmacy procedures.
- Merchandised over-the-counter goods and rotated stock.
- Received incoming supplies and stocked in correct locations.
- Assisted pharmacist by filling prescriptions for customers and responding to patient questions regarding prescription and medication-specific issues.
- Communicated instructions to patients or caregivers about proper use and storage of drugs.
- Assisted pharmacy staff with preparing medications and filling orders.
QC Officer
Cliantha Research
06.2019 - 06.2020
- Reported problems and concerns to management.
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
- Recorded and organized test data for report generation and analysis.
- Determined root cause of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout product development process.
- Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
- Conducted investigations into questionable test results.
- Developed and audited practices, programs and reporting system metrics for optimal efficiency.
Education
Post Graduate - Regulatory Affairs
Algonquin College
Ottawa, ON09.2022
Graduate Certificate - QA/QC in The Pharmaceutical Industry
Durham College
Oshawa, ON09.2021
Bachelor’s - Pharmacy
Gujarat Technological University
Gujarat, India 06.2015
Skills
- Industry Trends
- Software Platforms
- Bug Fixes
- Procedural Guidance
- Regulatory Compliance
- Regulatory Documentation
- Cost Savings
- Application Filing
- Clinical Trials
- Regulatory Monitoring
- Team Communication
- Submitting Files
- Outbound Marketing
- Margin Monitoring
- Standard Operating Procedure
- Drug Regulatory Affairs
- Audit Rating
- Method Validation
- Documentation Workflows
- SOP Development
- Quality Control Standards
- Emergency Preparedness
Timeline
Regulatory Affairs Intern
Lupos Biotechnology Company
04.2022 - Current
Pharmacy Assistant
Rexall
11.2021 - 11.2022
QC Officer
Cliantha Research
06.2019 - 06.2020
Post Graduate - Regulatory Affairs
Algonquin College
Graduate Certificate - QA/QC in The Pharmaceutical Industry
Durham College
Bachelor’s - Pharmacy
Gujarat Technological University
Similar Profiles
Riza VahoraRiza Vahora
Production Technician at Lupos BiotechnologyProduction Technician at Lupos Biotechnology
Sadaf AlizadehSadaf Alizadeh
Logistics Coordinator at Nahadeh Kara Industrial Biotechnology CompanyLogistics Coordinator at Nahadeh Kara Industrial Biotechnology Company
Luke WirinLuke Wirin
Pizza Delivery Driver at Lupos PizzaPizza Delivery Driver at Lupos Pizza