Monica Bravo- MBA, RAC, RCC

Experience

• 

  Davivienda

  Apr 1994 - Sept 2001

  Professional Operations
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  Alltech

  Jul 2007 - Apr 2012

  Latin America Regulatory Coordinator

  •Coordinate regulatory activities between Headquarters in Nicholasville, Kentucky and the Latin America countries, as well as within the Latin America countries.•Preparation of documents for registration dossiers to include: assembly, document coordination and compiling of information for Latin America region. •Control of pending approval of product registrations, daily correspondence and follow up with each country manager or local regulatory agencies to determine status and progress. •Prepare monthly reports to the various managers. •Acts as a company representative, developing and maintaining positive relationships with regulatory agencies, through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review. •Obtain answers to questions being raised in response to dossiers submitted to the local Ministry of Agriculture. •Provide regulatory guidance and direction as a core member on cross-functional teams. •Work with Production/Quality Assurance/Quality Control to ensure the product registration properly reflects the product. •Travel to LA to work with local offices and the local regulatory agencies. •Audit Latin American labels for accuracy of product information, general errors and adherence to registered specifications. •Verify and enter registration information and product specifications into the departmental database. •Initiate new document legalization as well as complete the process through the various consulates. •Translate assorted documents into Spanish and English. •Create and produce routine correspondence, reports and business documents. •Organize, maintain and update office and computer filing. •Participate in intra and inter-departmental projects and activities as assigned. Show less

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  Cook Biotech

  Apr 2012 - now

  Participate in and assist with strategic planning, leading and monitoring of international projects, as well as collaboration on international regulatory submissions.

  • Regulatory Affairs Operations Manager

    Jan 2022 - now

  • Inernational Regulatory Project Manager

    Jan 2019 - Dec 2021

  • International Regulatory Assistant Manager

    Jan 2017 - Dec 2018

  • International Regulatory Affairs Coordinator

    Jan 2014 - Dec 2016

  • International Regulatory Affairs Specialist

    Apr 2012 - Dec 2013