Chitrananda Abeygunawardana
About Chitrananda Abeygunawardana
Vice President, Regulatory Affairs
Chitrananda Abeygunawardana serves as the Vice President of Regulatory Affairs at Venatorx. In this role, he develops and executes regulatory strategies and tactics for antibacterial and antiviral programs. He interacts with health authorities and manages clinical trial applications worldwide. This position is a critical component of Venatorx's mission to advance innovative therapeutics.
Education and Expertise
Chitrananda Abeygunawardana holds a Ph.D. in Chemistry from the University of Maryland, Baltimore County (UMBC), and a B.S. in Chemistry from the University of Peradeniya in Sri Lanka. He also has extensive expertise in analytical and manufacturing aspects of vaccines and biologics, cGMPs, devices, content labeling, and manufacturing investigations.
Professional Background
With nearly 25 years of experience in pharmaceutical research, regulatory affairs, and compliance, Chitrananda Abeygunawardana has contributed significantly to the field. He previously served as Executive Director at Merck Global Regulatory Affairs and Clinical Safety (GRACS), where he led the development of regulatory strategies for multiple anti-infectives, including vaccines, antivirals, and antifungals. He also played a crucial role in Merck's pneumococcal vaccine strategy.
Achievements in Regulatory Affairs
Chitrananda Abeygunawardana has played a significant role in formulating late-stage clinical and regulatory strategies to maximize value through optimal labeling indications and content. He has led discussions with the FDA (CBER, CDER, & CDRH) and represented Merck in discussions with other key ex-US Agencies such as the EMA, Health Canada, PMDA, PEI, and CFDA. His extensive experience in new drug development support has been pivotal for various programs.