Neetha Thomas Email & Phone Number

Maryland, United States

I specialize in managing regulatory submissions for both the US and international markets, with a focus on post-marketing activities.My responsibilities include planning, preparing and submitting regulatory applications for new indications and license maintenance activities, ensuring compliance with regulatory requirements in the US and various international markets. This involves closely monitoring regulatory guidelines and requirements, coordinating with cross-functional teams to gather necessary documentation, and managing timelines to ensure timely submission and approval of regulatory applications.Additionally, I monitor and stay abreast of regulatory changes in both US and global markets, assessing the impact on our products and regulatory strategies. I collaborate closely with internal cross-functional teams to address new regulatory requirements or changes, ensuring that our products remain compliant and competitive in the global market.

Gaithersburg, Maryland, United States

In my role as a distribution manager, I have effectively overseen the distribution of clinical trial materials, prioritizing efficiency and compliance. With a strong track record, I have successfully managed inventory, coordinated shipments, and ensured the proper storage of temperature-sensitive materials. Moreover, I have experience in maintaining meticulous documentation to meet regulatory standards and fostering seamless communication among internal teams, vendors, and study sites. My ability to optimize distribution processes and address logistical challenges has contributed to the successful execution of multiple clinical trials

Owings Mills, Maryland, United States