Regulatory Affairs Analyst

1 semana atrás

Sao Paulo, Brasil Johnson & Johnson Tempo inteiro

We are searching for the best talent for REGULATORY AFFAIRS ANALYST to be in São Paulo/Brazil.You will be responsible for:- In partnership with the LATAM RA PMO executes registration strategies for designated regional projects related to new/existing products, according to local regulation, approved licenses, and RA Hub/Country alignment;- Adheres to environmental policy and procedures and supports department environmental objectives;- Works with LATAM RA Leadership and RA Country Owners to ensure rapid and timely approval of new and existing products;- Assists with ensuring compliance with regulatory agency regulations and interpretations;- Assists with the preparation of responses to regulatory agencies questions and other correspondence;- Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides;- Provides solutions to a variety of problems of limited scope and complexity. - Conducts searches of existing files for requested information;- Submission of payments/PO in SAP System related to the Regulatory area in LATAM;- Support to update LATAM database;- Support to request documents/deliverables in the Request Management System for LATAM- Support to download documents from Agile to set up technical dossier in LATAM;- Support to create the information of products to deliver to ours consults and distributors.- Partners with other functions to define and obtain regulatory deliverables to assist with local submissions or designated regional projects.- Updates relevant global, regional and local databases to ensure compliance. - Maintains and archives all regulatory documentation.**Qualifications****Requirements**:- Bachelor’s degree in health-related courses with a minimum of 1 year of Regulatory experience in a regulated industry (could include pharmaceutical, medical device, or associated consumer industries)- Fluent in Portuguese and advanced in English (written and verbal)- Intermediate Spanish level as a plus- Result-oriented, initiative, proactive- Team player- Good communication skills (collaborative approach), open-minded- Demonstrated ability to handle multiple projects**Primary Location**Brazil-São Paulo-São Paulo- **Organization**Abbott Prod Oticos Ltda (7602)**Job Function**Regulatory Affairs**Requisition ID**W

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