Alessandra Silva

Experience

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  Zoetis

  Aug 2010 - Apr 2013

  Responsible for registration of veterinary products in Europe, Africa and Middle East (EuAfMEcountries);Registration of products and dossier alignment in Latin America;Licenses renewals;Preparation and review of technical reports and SOPs. ● MODA Project - Mobile Data Acquisition:Data collection;Elaboration of Site Master Data;Strategic alignment;Elaboration of trainings;Support in system validation.● LIMS Project - Laboratory Information Management System:Compilation of data into the system;Review and adjustment of raw materials specifications;Elaboration of SOPs;Development and implementation of trainings and simulations. Samples receipt; Batch records conference; Emission and control of training lists; Separation of batch records to be used by Production; Implementation of project for interaction improvement between Quality Assurance and PCP.

  • Jr. Regulatory Affairs Analyst

    Jul 2012 - Apr 2013

  • Jr. Quality Control Analyst

    Oct 2011 - Jul 2012

  • Quality Assurance Intern

    Aug 2010 - Sept 2011
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  Ceva Santé Animale

  Apr 2013 - Apr 2016

  Regulatory Affairs Analyst

  ● January 2014 onwards (Export):Responsible for registration of veterinary products in Africa, Asia and Latin America;Management of Export projects (follow up, support, solving problems);Monthly meetings to update the headship of the department regarding the progress of ongoing projects;Constant preparation of dossiers and study of countries legislations;Attendance to authorities questions and support for licenses renewals;Management of processes regarding labels creation/change;Creation and maintenance of Export dossiers database;Active participation in audits conducted by international regulatory authorities;Member of CAMEVET Brazil working group;Import and export authorization request of finished products and raw materials at MAPA;Daily monitoring of Diário Oficial da União;Management of Dossier Alignment project (pharmaceutical products manufactured in Brazil) ;Support for Team Brazil - pharmaceutical products division.● April to December 2013 (Brazil):Registration of veterinary products in Brazil, at MAPA; Contact with local officials (Campinas city) of the Ministry;Registration amendments; Fulfillment of requirements and refusals; Licenses renewals; Import and export authorization request of finished products and raw materials at MAPA;Scheduling and preparation of documents for vaccines collection; Review of packaging material sayings; Update company information at MAPA, CRF, CRMV and other relevant authorities; Support to technical responsibles of the subsidiaries. Show less

• 

  Hill's Pet Nutrition

  Apr 2016 - now

  - People management (5 people);- Responsible for regulatory processes in Latin America: Brazil, Mexico and CASACA (Central America, South America and the Caribbean): 14 countries in total;- Project management (re-launches, innovations, licenses transfer, among others);- Innovation grid assessment;- Monthly meetings with Brazil and LATAM General Managers and biweekly meetings with RA Global Vice President, to share updates on the progress of ongoing projects;- Preparation of ingredients and pet food dossiers for Brazil;- Answering questions from MAPA, INMETRO, PROCON, CRMV and PROFECO;- Monitoring of formula changes and impact analysis;- Artworks, stickers and advertisement material review;- Creation and maintenance of the Regulatory Affairs database;- Close support and interaction with Marketing, Supply Chain and Professional Vet Affairs;- Active participation in trade Associations (Abinpet, Sindirações, Amascota);- Coordinator of Abinpet Technical Regulatory Committee;- Hill's Brazil Regulatory Representative before MAPA and Associations. Show less Regulatory Affairs Brazil representative;Mediator of the contact between Brazil and the Headquarter (US);Submission of pet food dossiers/RTPIs for new products and product changes;Submission of new ingredients dossiers;Attendance to authorities questions;Tracking of product changes and analysis of the impact for Brazil;Management of regulatory projects (follow up, support, solving problems);Biweekly meetings to update the headquarter in Topeka - KS, regarding the progress of ongoing projects;Monthly meetings to update the team in Brazil, regarding the progress of ongoing projects;Support for labels and marketing materials creation;Labels management;Creation and maintenance of Regulatory Affairs Brazil database;Close contact with Trade Associations (ABINPET and Sindirações);ABINPET Technical Committee member & ABINPET Norms' Coordinator;Support for technical areas (Professional Vet Affairs, Veterinary Territory Representatives and Customers Assistance) and third parties;Regulatory representative before MAPA and Associations meetings, Congresses and Seminars. Show less

  • Associate Manager, LATAM Regulatory Affairs

    Apr 2022 - now

  • Supervisor, LATAM Regulatory Affairs

    Apr 2020 - Apr 2022

  • Sr. Regulatory Affairs Analyst

    Oct 2018 - Mar 2020

  • Regulatory Affairs Analyst

    Apr 2016 - Sept 2018