Regulatory Affairs Specialist

3 semanas atrás

São Paulo, São Paulo, Brasil Johnson & Johnson Tempo inteiro
**Job Function**:
Regulatory Affairs Group
**Job Sub Function**:
Regulatory Affairs
**Job Category**:
Professional
**All Job Posting Locations**:
São Paulo, Brazil
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
**We are searching for the best talent for We are searching for the best talent for Regulatory Affairs Specialist - São Paulo-SP**
- Under supervision, it is responsible for regulatory activities to support and grow the business in line with the company goals. This includes:
**Principal Responsibilities**:
**Regulatory Policy & Intelligence**:
- Shapes & influences the regulatory environment including working on or commenting on Health Authority new regulations, future regulations and new approaches for current regulations through participation in discussion groups Trade Association as a team member.
- Participates in the Trade Associations working groups and meetings.
- Work with Regional Office within J&J and CMCs, as appropriate for new and/or updated Regulations that may impact.
**Regulatory Strategy**
- Prepare and submit regulatory submissions (e.g. ANVISA database corrections, DCB request, labeling notifications, leaflet notifications, variations, registration submissions amendments etc) and HA queries timely;
- Contribute to compliance with all regulatory requirements (e.g. timely submission of dossiers, timely implementation of new national and international legislation, timely implementation and training of SOP's & supporting systems) and regulatory systems;
- Regulatory Intelligence review for the products;
- Review promotional materials;
- Contributes with the regulatory strategy of new business projects for Brazil, including Marketing Authorization Holder

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