Amira UserAU
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Amira User

@amirauser2

Trilingual Regulatory Affairs and Compliance Specialist with pharmaceutical expertise.

Canada
Message

What I'm looking for

I am looking for a role that values regulatory excellence and offers opportunities for professional growth.

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

DI
Current

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.

GP

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.

GI

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.

Education

Degrees, certifications, and relevant coursework

AC

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.

FM

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

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