Bassem Aziz

I'm a career oriented individual who's always passionate about his career and serious about making a change and positively impacting other peoples lives.

{Regulatory Affairs Intern}

Cliantha Research Limited, Mississauga, ON

May 2024 – Present

• Preparing Applications to Regulatory Agencies in Canada (e.g. Clinical Trial Applications- Phase I, II, II and BA/BE, and related applications, ITA) and the US-IND and IDE.
• Preparation and submission of CTD in non-eCTD electronic only format.
• Support Communication with the regulatory agencies (e.g., Health Canada, EMEA, and FDA) and/or via the sponsor in response to regulatory issues raised in regulatory documents such as clarifaxes or deficiency letters as needed.
• Conduct and support all other Regulatory submissions, including but not limited to, SAEs, End of Study Notifications, Amendments, responses to clarifaxes and/or other submissions queries/questions/observations, etc.
• Providing support for applications for Controlled Substances Licenses, renewals, and/or amendments.
• Completion of Bioequivalence Summary Tables and Comprehensive Summary – Bioequivalence Report for Submission to regulatory authorities.

{Vet Assistant}

Beattie Animal Hospital, Hamilton, ON

July 2023 – December 2023

. Provided a high level of support to veterinarians and technicians and assisted with daily tasks in clinic.

. Loaded patients into examination rooms and filled out soap forms regarding patient’s health. 

. Cleaning cages, sanitizing medical equipment, and monitoring patient’s health. 

. Conducted patient follow-up check-ups.

. Monitoring patient’s weight and ensuring data quality & consistency. 

. Checked for medication errors and consulted with doctors to administer the correct dose and medicine based on patient’s health/history.

. Filled syringes with vaccines and provided drug information to patients.

{Field service technician-Food & beverage}

Ecolab, Toronto, ON

October 2021 – April 2022

• Conduct Cleaning Verifications.
• Support large plant start-ups.
• Install and maintain tank level monitoring equipment.
• Support the installation of plant level equipment.
• Perform basic service fundamentals like inventory, order placement, titrations, etc.

Post-Graduate Diploma in CLINICAL RESEARCH, PHARMACOVIGILANCE AND REGULATORY AFFAIRS

Academy of Applied Pharmaceutical Sciences (AAPS College), Toronto

Bachelor Of Science (Biology & Health Sciences)

Brock University, St Catherines, ON.