Prakash Patel

Prakash Patel has a strong background in regulatory operations and submission management within the pharmaceutical industry. Prakash is currently the Director and Global Head of Regulatory Operations at iTeos Therapeutics. Prior to this, Prakash worked as a Professor at Northeastern University, teaching a graduate course in Regulatory Affairs for Drugs, Biologics, and Medical Devices.

Before joining Northeastern University, Prakash served as the Senior Manager of Regulatory Operations at Sumitomo Dainippon Pharma Oncology, leading and overseeing the regulatory information management platform and developing submission management strategies. Prakash was also responsible for preparing and managing various regulatory submissions.

Earlier in their career, Prakash held positions at Roche and Cadista Pharmaceuticals. At Roche, they worked as both a Senior Manager and a Regulatory Submission Manager, overseeing the submission process of various regulatory documents. At Cadista Pharmaceuticals, Prakash worked as a Regulatory Affairs Specialist, providing strategic regulatory input and leading pre-approval and post-approval submission activities.

Overall, Prakash Patel brings extensive experience in regulatory operations and submission management to their current role, as well as a background in teaching and academia.

Prakash Patel holds a Master of Science degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, which they completed in 2016. Prior to that, they obtained a Bachelor's degree in Biology from the University of Maryland Eastern Shore, completing it in 2004. Additionally, they have obtained several certifications, including being a RAPS Member through the Regulatory Affairs Certification Program in 2015 and 2020. Prakash has also received training in Regulatory Affairs from Tata Consultancy Services and Liquent Education and Training in 2014, and has a recognition in Product Development Regulatory from Roche in 2013. Furthermore, they hold a Lean Six Sigma Green Belt certification from Tata Consultancy Services.