Sarah Ritchie

Background

About Sarah Ritchie

As a Regulatory Operations Specialist, I play a key role in supporting the preparation, publishing, and archiving of global regulatory submission documents. My work ensures submission readiness and compliance with regional and ICH guidelines by maintaining high standards in document formatting, metadata management, and electronic publishing. I have hands-on experience with: • Formatting Word documents and performing advanced PDF publishing (including hyperlinking and bookmarking) • Conducting quality control (QC) at both the document and submission levels • Managing metadata and electronic archiving in Veeva RIM • Supporting cross-functional teams by coordinating document routing, distribution, and submission tracking I’m also involved in process improvement initiatives such as updating SOPs, developing publishing templates, and contributing to the standardization of regulatory workflows. With a collaborative approach, I work closely with submission managers, document owners, and cross-departmental stakeholders to ensure timely, accurate, and compliant submissions. I’m passionate about regulatory excellence and leveraging technology to improve efficiency, data integrity, and global compliance in regulatory operations.