Christopher A. Almeda

Assistant Regulatory Affairs Coordinator @Uci Center For Clinical Research

Orange, CA, US

Regulatory Compliance: Ensuring full compliance with local, national, and international regulations, including preparing and submitting regulatory documentation to relevant authorities to ensure timely approvals.Documentation Management: Managing and maintaining accurate records of regulatory submissions, communications, and other critical documentation, ensuring easy retrieval and audit readiness.Audit and Inspection Support: Assisting in the preparation for regulatory audits and inspections by gathering necessary documents, providing relevant information, and supporting the team through compliance activities.Electronic Regulatory System Management (Complion): Managing and maintaining submissions and regulatory documentation within the Complion electronic regulatory system. Responsible for the oversight of Investigational Site Files (ISFs) through the system to ensure accuracy, consistency, and compliance.IRB Communications: Liaising with Institutional Review Boards (IRBs) for study approvals, providing updates on amendments, and ensuring that all necessary submissions and amendments are completed in a timely manner.

Whittier Christian High School

High School Diploma

Penn State College of Medicine

Master of Public Health - MPH, Global Health certification, Public Health

Penn State University

Bachelor's of Science - BS, Spanish minor, Biology, General