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...