Sharath Shashiraj

WORK HISTORY

EDUCATION

ABOUT SHARATH SHASHIRAJ

As a seasoned Strategic Regulatory Affairs Specialist, I bring a wealth of expertise in navigating the intricate landscape of biological, pharmaceutical, and various product types within organizations. My track record includes adeptly managing a diverse array of product registrations and fostering productive interactions with regulatory bodies such as USFDA, CDSCO, DCDK, GEAC, RCGM, OPPI, ICSR, and FSSAI. I excel in crafting comprehensive regulatory strategies and overseeing technical aspects for both existing and new product development and registration processes. My proficiency extends to managing pre- and post-approval regulatory activities, encompassing safety reporting, securing new drug approvals, conducting market research, and ensuring meticulous documentation and control measures. In addition, I possess specialized skills in regulatory project management, where I efficiently coordinate project workflows, set clear objectives, establish precise timeframes, and oversee project progress to ensure timely completion. My proactive and forward-thinking approach enables me to anticipate future trends and consequences, fostering innovative and integrated strategies for regulatory affairs. As a thoughtful and effective team leader, I have successfully led multifaceted teams of regulatory associates, driving them toward the attainment of both organizational and personal goals with efficiency and precision. To know more about me or my work, please drop me a line at r••••••••@gmail.com.