Kamesh Kuchimanchi is a professional in the area of regulatory affairs. Throughout his career, Kuchimanchi has seasoned his command of global strategic regulatory development of biologics and drugs in various therapeutic areas.
What is Regulatory Affairs?
Public safety is the cornerstone of all approaches in regulatory affairs. In short, regulatory affairs refers to the management and implementation of regulating industries in terms of quality, safety and effectiveness. Various subsets within the realm of healthcare are protected and improved through the process of regulatory affairs.
Throughout his career, Kamesh Kuchimanchi has fine tuned his focus in regulatory affairs as applicable to oncology. Currently, Kuchimanchi represents Boston Biomedical Inc.’s Sumitomo Dainippon Global Oncology Unit as the Executive Director of regulatory affairs. Through this role, he executes complex study design changes in accordance with FDA policies and regulations. Several aspects of Kuchimanchi’s Executive Director role are managerial in nature. He is tasked with managing and mentoring other members of Boston Biomedical’s regulatory affairs team, which includes providing strategic guidance in the way of development programs within the DSP and BBI program portfolios.
Prior to his promotion to Executive Director in 2018, Kamesh Kuchimanchi represented Boston Biomedical’s regulatory affairs department as Senior Director. Under this role, he acted as a leader in supporting in-licensing and acquisition activities, as well as the management of the oncology portfolio.
Previous regulatory affairs positions held by Kamesh Kuchimanchi include:
- Vice President of RA at Odonate Therapeutics, LLC (2017)
- Senior Director of Global RA at Shire Inc (2016 – 2017)
- Senior Director of Global RA at Baxter/Baxalta US Inc. (2014 – 2016)
- Director of Global RA at Baxter Healthcare/Baxter BioScience (2014)
- Associate Director of Global RA at Baxter Healthcare/Baxter Bioscience (2009 – 2014)
Kamesh Kuchimanchi looks forward to continuing his career in the area of regulatory affairs. He finds both professional and personal fulfillment in contributing to the implementation and advancement of scientific experiments for the benefit of public health. It is Kuchimanchi’s ultimate goal to make a lasting impact on his industry. Before reaching retirement, the professional hopes to make his mark by revolutionizing how the public views regulatory affairs.