Lorena Taroco

Experience

• 

  IQVIA

  Jun 2007 - now

  Acts as Global Regulatory Advisor• Assist with creation and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance.• Establishes relationships with many customers. Participation by phone or in person in Kick off meetings and Bid Defense Meetings.• Preparation of RA and EC submissions plan, RA and EC submissions required documents tracker, core package, core cover letters and QC of core package.• Generates and/or QC reviews of master ICFs, master labels, Delegation letters. Coordination of ICFs, labels, Delegation letters preparation for all the countries.• Managing submissions to VHP.• Preparation and deliver of regulatory training and lessons learned. Show less • Acts as a Regulatory Team Leader for Latin America countries and establishes relationships with customers. • Acts as RSU specialist for Argentina.• Preparation and/or review of ICFs, DLs, labels, EC/RA submission packages, CTAs at country level and at regional level.• Managing EC and RA submissions at country level. Main point of contact for RA/EC/sites at country study level.• Participation on Investigator Meetings.• Preparation and deliver of regulatory training. • Preparation and/or reviews of regulatory documentation. Show less

  • Global Regulatory Advisor

    Apr 2012 - now

  • Regulatory Affairs Officer II

    Mar 2011 - Mar 2012

  • Regulatory Affairs Officer I

    Jul 2008 - Feb 2011

  • Regulatory Affairs Associate

    Oct 2007 - Jun 2008

  • Sr. Regulatory Affairs Coordinator

    Jun 2007 - Sept 2007