Agnes Bancerz
Associate Regulatory Program Director @Roche
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WORK HISTORY
Associate Regulatory Program Director @Roche
EDUCATION
University of Toronto
Honours Bachelor of Life Science
Seneca College of Applied Arts and Technology
Post-Graduate Certificate, Pharmaceutical Regulatory Affairs and Quality Operations with Honours
ABOUT AGNES BANCERZ
Key Capabilities in Global Regulatory Affairs: Performing global regulatory relevance assessments for changes and completing regulatory impact assessments for deviations for biologics and small molecules for major markets US/EU/Canada/China/Japan; Authoring and reviewing M1, M2 and M3 dossier sections, RIM submission planning; Compiling responses to Health Authority Queries (HAQ). Successful submissions to the following global markets: US/FDA, EU (NAP/MRP), EAEU, Brazil, Japan, Russia and Thailand. Proven track record for cross-functional collaboration and high quality submissions and regulatory assessments. Key Capabilities in Global Quality Operations: Experienced Business Process Manager for Pharmaceutical Quality Systems (PQS) and Document Management. Authored CMO Annual Product Quality Reviews (APQR) and SOPs/WIs, implemented new applications and improved processes for external quality network driving continuous improvement projects and innovation, proficient in change control/deviations/CAPAs, participated in internal as well as Health Canada and Swissmedic audits and inspections.
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