Regulatory Affairs Analyst

1 semana atrás

São Paulo, São 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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