Remote Regulatory affairs Jobs · ICH-GCP

• Responsible for site activation readiness, submission preparation, and interaction with Competent Authorities and Ethics Committees.
• Manage essential document collection, informed consent customization, and maintain project plans and trackers.
• Partner with cross-functional teams and act as subject matter expert for country-specific regulatory knowledge.

We are a global life sciences company specializing in clinical trial regulatory and start-up services. We are expanding our capabilities across Latin America and seek experienced professionals to join our team.

• Independently conduct on-site and remote monitoring visits (SQVs, SIVs, IMVs, COVs) per protocols and regulations.
• Manage site relationships, perform source data verification and review, and resolve data discrepancies.
• Track monitoring findings, escalate risks, and maintain inspection-ready documentation.

Karius is a venture-backed life science company focused on clinical metagenomics, using genomics and AI to detect infectious diseases from microbial DNA in blood. The company is dedicated to advancing diagnostic science and improving patient care.

• Conduct risk-based quality control assessments and on-site visits to ensure investigational sites adhere to study protocols, GCP, and company procedures.
• Develop and maintain study-specific QC plans, tools, and reports, and drive trend analysis and issue resolution with clinical operations teams.
• Support inspection readiness and contribute to training and process improvements based on QC findings and regulatory insights.

Zai Lab is a commercial-stage biopharmaceutical company focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and worldwide. Founded in 2014, the company has a global team of about 2,000 employees, with a strong commitment to gender diversity and a culture that promotes women in biotech.