Regulatory Affairs Specialist

We are seeking a Regulatory Affairs Specialist in Brazil to support local regulatory submissions within a global clinical trial environment. This role focuses on submission-related activities, collaboration with internal teams and sponsors, and ensuring compliance with local and global regulatory requirements. It is an excellent opportunity to further develop regulatory expertise while contributing to clinical research initiatives in Brazil.

As a Regulatory Affairs Specialist, you will play a key role in supporting local regulatory activities related to clinical trials. Your responsibilities will include preparing and compiling regulatory submissions to ANVISA for clinical trial applications and clinical development dossiers covering drugs, biologics, advanced therapies, and medical devices.

You will interact regularly with sponsors, internal stakeholders, and regulatory authorities, and will review and assess clinical trial regulatory documentation to ensure accuracy, quality, and compliance. You will be responsible for entering and maintaining trial status information related to regulatory affairs activities within tracking databases in a timely and accurate manner.

The role also involves maintaining local country study files and filing processes in line with company procedures or applicable client SOPs. You will participate in project team meetings, contribute to the development and implementation of project-specific processes, and attend meetings with local associations to support initiatives that promote clinical trials in Brazil.

This position requires strong organizational, analytical, and communication skills, the ability to work independently, and a solid understanding of local and global regulatory requirements for clinical trial authorization, including relevant international guidelines.