Tyler Rudin, MBA
About Tyler Rudin, MBA
Tyler Rudin is a Senior Manager of Regulatory Project Management at Arcus Biosciences, where he has worked since 2022. With a background in regulatory affairs and project management, he has experience in leading integration activities for drug products and mentoring staff in regulatory processes.
Work at Arcus Biosciences
Tyler Rudin has been serving as the Senior Manager of Regulatory Project Management at Arcus Biosciences since 2022. In this role, he leads pivotal integration activities for Otezla, focusing on the development of Global Integrated Regulatory Strategy Documents and overseeing Marketing Application transfers. He collaborates closely with process development staff to ensure the timely completion of authoring, data verification, and reviews of global regulatory filings for drug product presentations and tech transfers.
Previous Experience at Amgen
Before joining Arcus Biosciences, Tyler Rudin worked at Amgen as a Regulatory Affairs Manager in the CMC department from 2013 to 2021. During his eight years at Amgen, he was involved in various regulatory affairs activities, contributing to the management of regulatory processes and ensuring compliance with industry standards. His experience at Amgen provided him with a strong foundation in regulatory project management.
Experience at Atara Biotherapeutics
Tyler Rudin also held the position of Senior Manager for Strategic Planning & Operations at Atara Biotherapeutics from 2021 to 2022. In this role, he was responsible for overseeing strategic initiatives and operations within the organization. His time at Atara Biotherapeutics further enhanced his expertise in regulatory project management and strategic planning.
Education and Expertise
Tyler Rudin earned his Master of Business Administration (MBA) from California Lutheran University, completing his studies from 2017 to 2021. Prior to that, he obtained a Bachelor's Degree in Psychology from the University of California, Los Angeles, where he studied from 2010 to 2013. His educational background provides him with a diverse skill set applicable to regulatory project management and strategic operations.
Regulatory Management and Mentorship
In his current role, Tyler Rudin manages the Regulatory Assessment Form (RAF) process, focusing on training and implementing process improvements to enhance execution efficiency and accelerate expiry assignments. He also mentors and trains staff on routine regulatory activities, providing technical advice to global leads. Additionally, he monitors data accuracy in tracking systems such as Veeva and Amgen RIM through collaboration with Global and Regional RA CMC Leads.