. Manages and organizes the Regulatory Affairs Department team.. Supervises the preparation of e-CTD/CTD dossiers for new Marketing Authorizations applications and variations : MRP/DCP/National procedures• Provides in-depth information to the Managing Directors about the current legislation and regulatory due-diligence to overcome legislative hurdles, applying appropriate Regulatory Affairs Strategies around the world• Collaborates closely with Managing Directors to determine new product development strategies and with R&D Department to define and follow all the development stages of the new products. Supports the new products' launch and all the activities needed during products' lifecycle . Supports Business Development Department for all license out activities and customer service issues. Responsible for pricing and reimbursement issues

. Manages and organizes the Regulatory Affairs Department team, offering regulatory due-diligence for overcoming legislative hurdles and applying appropriate strategies around the world. Supervises the preparation of e-CTD/CTD dossiers for new Marketing Authorizations applications and variations : MRP/DCP/National procedures. Collaborates closely with Product Development Manager and R&D Manager in all the development stages of the new products. Supports Marketing & Sales Manager in new products' launch and during lifecycle . Supports Business Development Director in license out activities and customer service issues. Responsible for pricing and reimbursement issues