Sai Krishna D.
About Sai Krishna D.
Sai Krishna D. is a Manager of Regulatory Affairs Operations with nearly a decade of experience in the pharmaceutical industry, specializing in document management and regulatory compliance. He holds a Master of Science in Project Management from Northeastern University and a Master of Science in Clinical Pharmacology from the University of Aberdeen.
Work at CytomX Therapeutics
Currently, Sai Krishna D. holds the position of Manager, Regulatory Affairs Operations at CytomX Therapeutics. He has been with the company since 2021 and has accumulated three years of experience in this role. His responsibilities include overseeing regulatory affairs operations and ensuring compliance with industry standards. His expertise contributes to the development and management of regulatory strategies within the organization.
Education and Expertise
Sai Krishna D. possesses advanced degrees in relevant fields. He earned a Master of Science in Project Management from Northeastern University, studying from 2016 to 2018. Additionally, he completed a Master of Science in Clinical Pharmacology at the University of Aberdeen from 2009 to 2010. His educational background supports his expertise in regulatory affairs, particularly in preparing Standard Operating Procedures (SOPs) and process guides.
Background in Regulatory Affairs
Sai Krishna D. has a solid background in regulatory affairs, with approximately 10 years of experience in the pharmaceutical industry. Prior to his current role, he worked at Johnson & Johnson as a Regulatory Affairs II (Submissions Manager) from 2017 to 2020. He then served as a Regulatory Affairs Operations Specialist III at Sangamo Therapeutics, Inc. from 2020 to 2021. His experience spans various aspects of regulatory operations, including document management and compliance.
Technical Skills and Tools
Sai Krishna D. has working knowledge of several regulatory tools and systems, including Veeva, Regulatory Information Management (RIM), and electronic Common Technical Document (eCTD) publishing tools. His technical skills enhance his ability to manage regulatory submissions and ensure efficient document management and archiving processes within the pharmaceutical sector.
Regulatory Knowledge and Compliance
Sai Krishna D. possesses regulatory affairs knowledge specific to both FDA and EU regions. This expertise allows him to navigate complex regulatory environments and contribute to the successful submission of documents and compliance with regulatory requirements. His understanding of these regulatory frameworks is vital for the operations he manages at CytomX Therapeutics.