Elsa Saade Email & Phone Number

Montreal, Qc, Ca

Montreal, Quebec, Canada

Montreal, Quebec, Canada

• Lead the pilot conversion of Product Monographs to the Extensible Markup Language (XML) format following Health Canada’s guidelines collaborating in a multi-disciplinary setting with internal and external stakeholders. • Prepare and file regulatory submissions as SNDS, Notifications, post-market PV monitoring. • Provide regulatory assessments for post-NOC quality changes and update related e-CTD Modules. • Conduct regulatory intelligence activities and monitor updates in… Show more • Lead the pilot conversion of Product Monographs to the Extensible Markup Language (XML) format following Health Canada’s guidelines collaborating in a multi-disciplinary setting with internal and external stakeholders. • Prepare and file regulatory submissions as SNDS, Notifications, post-market PV monitoring. • Provide regulatory assessments for post-NOC quality changes and update related e-CTD Modules. • Conduct regulatory intelligence activities and monitor updates in regulations and guidance documents.• Provide support in establishing regulatory strategies.• Ensure compliance with local regulations. • Prepare responses to Health Canada requests for information. • Update and maintain internal regulatory database and systems (Veeva Systems). • Manage the maintenance of the lifecycle of marketed products. • Review labels, promotional and non-promotional material to ensure compliance with local regulations. • Manage registrations and applications on internal regulatory information management systems. • Participate in preparation for internal audits. Show less

Canada

-Led and managed the conversion of the company's Product Monographs to the XML format following Health Canada's new requirements.-Performed regulatory intelligence activities and monitoredupdates in regulations and guidance.-Ensured the maintenance of marketed products lifecycle.-Provided support in the review of promotional and non promotional material.-Provided support in the preparation of drug submissions for Health Canada review and approval.

-Coordinator in Phase 2 and Phase 3 clinical trials for RNAinterference medications for Primary Hyperoxaluria.-Good Clinical Practice, planned and assisted in conductingpatients visits, filling source documents and online studydatabase.-Ensured compliance with federal guidelines and institutionalpolicy.

-Rotated in Pediatrics, Oncology, Cardiology and Urology Units.-Assessed patients' therapy protocols and suggested a planusing the SOAP technique.-Managed to give drug Information pertaining to drugInteractions, pharmacokinetics, pharmacodynamics.

Master'S Degree, Pharmaceutical Sciences Drug Development

Dess In Drug Development, Pharmacy

Activities and Societies: Vice president of internal affairs at the students' organization.

Master'S Degree, Pharmaceutical And Biological Sciences

Pharmacy, Pharm.D

Bachelor'S Degree, Medicine

High School Diploma