PROFESSIONALS SUMMARY With a decade of experience in the Pharmaceutical Industry, I bring a wealth of expertise in Regulatory and Compliance Enforcement, GMP Audit Inspections, and Regulatory Affairs. My background includes a Master’s Degree in Biomedical and Pharmaceutical Sciences and a Postgraduate Advanced Diploma (D.E.S.S) in Drug Development and Regulation, specializing in Drug Regulatory Affairs from the University of Montreal, Canada.I am known for being highly analytical, meticulous, and reliable, with a proactive approach to problem-solving. My skill set includes Quality Assurance/Quality Control Conformity, Supplier Qualification and Certification, and the ability to manage priorities under tight deadlines and frequent changes. I thrive in dynamic, multi-diverse environments and am fluent in both English and French.Collaboration and communication are at the core of my work ethic, making me a valuable partner in any regulatory or compliance-focused project. I am dedicated to driving results, maintaining the highest standards of compliance, and contributing to the continuous evolution and innovation in the pharmaceutical field. COMPETENCES • Regulatory and Compliance enforcement regarding HC, US FDA, ISO, ICH, EU MDR, and regulations impacting cGMP/ ISO operations.• Proficiency in GMP Audit Inspections with Health Canada or US FDA.• Qualification and Certification Program of Suppliers.• Great proficiency in Establishment Licenses Management, Maintenance and Annual Licenses Reviews with Health Canada. • Great proficiency in Quality Assurance Agreement Negotiations, Management and Maintenance.• Subject Matter Expert (SME) in Compliance related Change Controls Evaluations and Reviews.• Expertise in the Preparation, Review of Regulatory Submissions with Health Canada.• Proficiency in Microsoft 365 Office, SAP System and TRACK-WISE System for Change Controls, Deviations and Complains traceability tool.
Listed skills include Regulatory Affairs, Gmp, Drug Development, Glp, and 16 others.
