Daniel Abou-Chakra Email & Phone Number

Mississauga, Ontario, Canada

I lead regulatory strategies for medical devices, NHPs, pharmaceuticals, and cosmetics in Canada, ensuring compliance. My role involves guiding a multi-national team, enhancing our Canadian market support. This position underscores my skill in navigating regulatory complexities, upholding quality, and fostering strategic, cross-border collaborations. I.

Mississauga, Ontario, Canada

Medline acquired Medical Mart in March 2016. Among the many changes to Medical Mart's business infrastructure, Medline offered a robust regulatory program. A few years after the acquisition, I transitioned into the Regulatory Specialist role, taking on new challenges, and further investing my time in learning the inner working of Medline's business and.

Mississauga, Ontario

My main focus was to oversee quality operations. - Maintained QMS and all quality records (deviations, CAPAs, change controls, procedures)- Hosted Health Canada inspections- Implemented new procedures- Process improvements via Kaizen- Handled complaints, recalls and return analysis- Reviewed and negotiated quality agreements- Hired and supervised QA staff.

St Thomas, Ontario

• Planned and executed all activities necessary for the registration of new products and line extension for human and animal health products (Canada/US)
• Ensured Establishment Licences and Drug Establishment Registrations were renewed and amended punctually (Canada/US)
• Completed forms & requests from government agencies (Canada/US)
• Maintained contact with authorities as designated contact person
• Involved in preparing Quality agreements
• Provided project teams with regulatory and QA input

Controlled Drugs Section- Office Of Controlled Substances- Health Canada

* Reviewed security proposals, and assessed security plans and schematics against the Directive on Physical Security Requirements for Controlled Drugs * Requested security inspections for licensed dealers and liaised directly with regional Inspectorate offices to address any security and storage non compliance issues* Gathered statistical information on.

Precursor Chemicals Section - Licences And Permits Division

-Monitored Precursor Chemical activity in Canada to prevent possible diversion to the elicit market. -Processed existing and new licenses to ensure companies are in compliance with the Controlled Drugs and Substances Act and the Precursor Control Regulations. -Address outside inquiries for information from the CBSA, RCMP or potential licensed dealers..

Barrie, Ontario

- Resolved all leasing inquiries and customer complaints promptly- Set and attained monthly, weekly and daily goals and updated accordingly - Prepared and implemented open house and special promotional weekends - Monitored depreciation, pricing margins and idle inventory counts of products - Inspected all products, both in the showroom and storage, for.

Raqc, Regulatory Affairs

Honours Bachelor Of Science, Human Biology

Activities and Societies: Russian Student Association