Junior Regulatory Affairs Analyst

Location: Santo Amaro

Job Description Summary

#LI-Hybrid

São Paulo, Brazil

Relocation Support: This role is based in São Paulo, Brazil. Novartis is unable to offer relocation support: please only apply if accessible.

Drive regulatory excellence where it truly matters. As a Junior Regulatory Affairs Analyst, you will contribute to maintaining product registrations and ensuring ongoing regulatory compliance by supporting timely and compliant lifecycle submissions. Working within Regulatory Affairs, you will collaborate with cross-functional teams to support post-approval activities, prepare and maintain regulatory documentation, and ensure alignment with evolving local and international regulatory requirements. This is a great opportunity to build your regulatory expertise while contributing to the continued availability of medicines to patients within a global organisation committed to improving lives.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for renewals and variations
• Review technical documentation to ensure compliance with local and international regulatory requirements
• Prepare and maintain regulatory documentation and legal certificates
• Provide guidance to internal stakeholders on regulatory requirements, timelines, and documentation
• Maintain accurate regulatory databases, tracking systems, and activity records
• Ensure consistent compliance with internal procedures, regulatory standards, and submission deadlines