Mihai Bilanin

• Supporting a team of 5 RA Associates in the compilation/review of submissions (solid and liquid dose) in the Canadian, US, EU and International markets. • Company Expert on European Product Life Cycle Management. • RA assessor/approver of Global Change Control documents and Quality Notifications (Deviations). • Regulatory representative for quality initiatives including Product Remediation, Change Control, API Changes • Regulatory site lead for a major manufacturing site

• Until May 2009 I fulfilled a dual function since I have also continued my work as an EU CMC PLCM Senior Associate for Apotex Europe BV. • Company Expert on European Product Life Cycle Management. • RA assessor/approver of Global Change Control documents and Quality Notifications (Deviations). • Responsible for the compilation/review of documentation for the global (EU, CAN, US, AUS and other international) regulatory submissions • Corporate Project Manager for an EU Batch Release Site name change

• Preparing and updating dossier documentation (all CTD modules) for the EU National, MRP, DCP • Responsible for the preparation and review of CMC regulatory EU submissions • Coordinating the CMC regulatory EU submissions (variations) with our local affiliates • Conducting due diligence for our in-license dossiers • Making complex interpretation and application decisions relating to EU CMC regulatory submissions and guidelines • Prepare and/or draft department regulatory guidelines

Global markets responsibilities

US market responsibilities

• Preparing dossier technical reports like method validation, stability studies, comparative dissolution, analytical data summaries and impurity survey reports after reviewing all laboratory technical reports / data. • Issuing change controls for specifications and analytical procedures of new products. • Preparing summaries of deficiencies noted during the review of laboratory technical reports. • Ensuring the accuracy of calculation

• Performing GC and HPLC method development, validation, evaluation, investigation and troubleshooting of new analytical test procedures for the determination of potency and purity of experimental products. • Conducted stress and compatibility studies on drug substances and proposed drug product formulations. • Pharmaceutical analysis, release and stability testing for the determination of potency and purity of experimental products (including finished products and raw materials).

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