Cecile Cualing

WORK HISTORY

EDUCATION

ABOUT CECILE CUALING

I am a Pharmacist in a Regulatory Affairs capacity with proven expertise in technical data analysis combined with pharmacological and clinical knowledge. I have specialized skills in high-risk medical devices and Pharmaceutical submission. I have proven record of accomplishment in achieving early device licensing, effective strategic planning, driving collaboration, influencing business partners, and negotiating for positive outcomes with Health Canada. Effectively leads inter-departmental, cross-functional teams, and business partners to ensure accurate communication of regulatory strategies. Ability to anticipate Health Canada questions to obtain early licensing. Active member of Canadian Association of Professional Regulatory Affairs (CAPRA) and Canadian Pharmacist Associations.Core competencies include:• Canadian Food and Drug Regulations, FDA and International Agencies• ISO 13485, MDSAP, GMP, ICH, IMDRF, DIN, NDS, ANDS, CTD, e-CTD/STED Formats• Establishment and Site Licenses• Change Notices (Level 1, and IV) and Product Change Assessment• Product Lifecycle Management• High Risk Product Submission • Negotiation & Collaboration• Chemistry, Manufacturing and ControlsQuality Assurance Management:Contributed to the development and implementation of Quality and Compliance policies, GMP/cGMP/Quality training, writing and revising SOP and Change Control, Review and Approval of Change Notices and Supplemental Changes, Confirmatory Testing, Stability Testing and BPR. Writes Annual Product Quality Review (APQR).Portfolio Expertise: Pharmaceutical and Interventional Solution. Hemodialysis, Cardiovascular, Psychiatric, Neurologic,Urology Endovascular, Neurovascular, Orthopaedics, Software, and Imaging products