Principal Regulatory Affairs, Study Start Up Specialist

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Regulatory Affairs, Study Start Up Specialist based in Brazil.

This role sits at the center of global clinical trial start-up and regulatory execution, ensuring studies are initiated efficiently, compliantly, and in alignment with country-specific and international requirements. You will oversee end-to-end regulatory submissions, ethics and competent authority interactions, and the preparation of essential study documentation across multiple regions. Acting as a key regulatory expert, you will guide cross-functional teams, sponsors, and sites through complex submission pathways while ensuring accuracy, consistency, and compliance at every step. The position also plays a critical role in study start-up strategy, including submission planning, document quality control, and readiness for regulatory “green light” approval. You will collaborate in a highly international environment, contributing to process improvements, mentoring regulatory staff, and supporting inspections and audits. This is a high-impact role for an experienced regulatory professional who thrives in structured, detail-driven, and global clinical research environments.

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Regulatory Affairs, Study Start Up Specialist based in Brazil.

This role sits at the center of global clinical trial start-up and regulatory execution, ensuring studies are initiated efficiently, compliantly, and in alignment with country-specific and international requirements. You will oversee end-to-end regulatory submissions, ethics and competent authority interactions, and the preparation of essential study documentation across multiple regions. Acting as a key regulatory expert, you will guide cross-functional teams, sponsors, and sites through complex submission pathways while ensuring accuracy, consistency, and compliance at every step. The position also plays a critical role in study start-up strategy, including submission planning, document quality control, and readiness for regulatory “green light” approval. You will collaborate in a highly international environment, contributing to process improvements, mentoring regulatory staff, and supporting inspections and audits. This is a high-impact role for an experienced regulatory professional who thrives in structured, detail-driven, and global clinical research environments.

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

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