Amira User
@amirauser2
Trilingual Regulatory Affairs and Compliance Specialist with pharmaceutical expertise.
What I'm looking for
I am a trilingual Regulatory Affairs and Compliance Specialist with over 10 years of experience in the pharmaceutical industry. My expertise lies in regulatory compliance, quality assurance, and health systems management. I have a proven track record of interpreting and applying health regulations, preparing regulatory submissions, and leading audits to ensure compliance with both international and Canadian standards.
Throughout my career, I have demonstrated my ability to collaborate cross-functionally, develop policies, and make evidence-based regulatory decisions. I have successfully managed end-to-end regulatory submissions for medical devices and negotiated with international suppliers for exclusive distribution rights. My experience includes maintaining audit readiness, ensuring compliance with SOC2 Type 2, and authoring policies and SOPs that align with corporate practices.
Experience
Work history, roles, and key accomplishments
Compliance Specialist
DistillerSR Inc.
Oct 2024 - Present (9 months)
Maintained year-round audit readiness using the Drata compliance automation platform and ensured timely CAPA resolution. Authored, reviewed, and updated policies and SOPs in alignment with corporate practices.
Pharmacy Assistant
Guardian Pharmacy
May 2024 - Present (1 year 2 months)
Received and processed prescription orders, including measuring and packaging medications. Maintained inventory, monitored stock levels, and provided customer service to patients in virtual clinics.
Manager – Regulatory & Compliance Oversight
ANNABDA
Mar 2013 - Present (12 years 4 months)
Managed end-to-end regulatory submissions for Medical Devices and negotiated with international suppliers for exclusive distribution and marketing rights. Ensured compliance with import controls and labeling requirements.
Medical Representative
GALPHARMA Pharmaceutical Industry
May 2009 - Present (16 years 2 months)
Promoted pharmaceutical products while ensuring alignment with promotional guidelines. Acted as a liaison between prescribers, pharmacists, and the pharmaceutical industry.
Quality Assurance Pharmacist
TERIAK Pharmaceutical Industry
Jan 2009 - Present (16 years 6 months)
Developed and revised GMP-compliant policies and batch documentation. Prepared quality assurance reports and ensured alignment with health regulatory standards.
Education
Degrees, certifications, and relevant coursework
Algonquin College
Graduate Certificate, Regulatory Affairs
Completed a Graduate Certificate in Regulatory Affairs, earning a place on the Dean's list. Focused on understanding and applying regulatory frameworks relevant to various industries.
Faculty of Pharmacy of Monastir
Pharmacy Diploma, Pharmacy
Obtained a Pharmacy Diploma, assessed by WES as equivalent to a Master's degree in Canada and recognized by PEBC Canada as equivalent to a Bachelor of Pharmacy (B.Pharm). This program provided a comprehensive understanding of pharmaceutical sciences and practices.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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