MS OFFICE


Motivated and detail-oriented Regulatory Affairs Professional with a Doctor of Pharmacy and a Master's in Regulatory Affairs.
Developed skills in highly regulated environment, focusing on compliance (ICH-GCP, FDA, Health Canada), SOP development, regulatory submissions, and quality assurance. Expertise in navigating complex regulatory frameworks and ensuring adherence to standards. Seeking to transition into new field where impactful regulatory experience and strong analytical skills can be leveraged for organizational success.
Health Canada-Based Capstone
Global Regulatory Submissions: IND, CTA, NDA, IMPD
GxP Compliance: ICH-GCP, FDA, Health Canada
Clinical Trials, Pharmacovigilance, SOP Writing
Regulatory Documentation, Quality Assurance
Microsoft Office Suite (Word, Excel, PowerPoint)
Technical Writing & Risk Assessment
Regulatory compliance
Drug classification
Safety protocol adherence
FDA, Health Canada and HIPAA compliance
MS OFFICE