Catherine Jarvis

Background

About Catherine Jarvis

This position reports to the CMC Regulatory Change Management Senior Manager and is responsible for driving efficient submission execution while assuring product compliance through timely and accurate maintenance of CMC product knowledge in CMC Regulatory and PGS quality systems. Main activities for this role include submission strategy responsibilities, systems and regulatory change management compliance, submission document maintenance, and related CMC publishing support. Maintenance of the expansive combination of CMC product information, market registration details, component level dossier content, and an integrated change management process is essential both for providing a comprehensive view of, and supporting compliance with the CMC registered details of all products in all markets. This role is part of a team of technical aligned CMC experts connected directly to CMC Product Strategists in conjunction with CMC Advisory Office, WSR-I, WRO, and PGS colleagues who are accountable for expeditious and efficient submission execution and CMC product registration/application compliance through timely and accurate maintenance of CMC content (particularly Module 3 Regulatory Commitments).