Mahalingam Ramalingam, Rac
About Mahalingam Ramalingam, Rac
Mahalingam Ramalingam is a Senior Manager in Global Regulatory Science at Bristol Myers Squibb, specializing in CMC for devices and combination products.
Title and Current Position at Bristol Myers Squibb
Mahalingam Ramalingam holds the position of Senior Manager in Global Regulatory Science - CMC (Devices and Combination Products) at Bristol Myers Squibb. In his role, he focuses on regulatory submissions and strategies for medical devices and combination products. His efforts support the regulatory compliance and approval processes, ensuring adherence to relevant guidelines and standards in the United States.
Previous Experience at Fresenius Kabi USA
From 2019 to 2021, Mahalingam Ramalingam worked at Fresenius Kabi USA as a Senior Regulatory Affairs Specialist specializing in Combination Products and CMC. He operated in the Greater Chicago Area, engaging in regulatory strategies, premarket approval processes, and staying updated with evolving investigational device exemptions. His responsibilities included interpreting and applying regulatory standards such as ICH guidelines, GCP, and GMP.
Educational Background and Expertise
Mahalingam Ramalingam earned a Master's degree from Northeastern University in Pharmacy Administration and Pharmacy Policy and Regulatory Affairs, completing specialized training in Project Management for Regulatory Affairs in Drugs, Medical Devices, and Biologicals from 2017 to 2018. Before this, he completed a Bachelor of Pharmacy degree at Sri Ramachandra University, where he focused on Pharmacy Administration and Pharmacy Policy and Regulatory Affairs. His academic background provides a strong foundation for his expertise in regulatory submissions, strategies, and standards.
Industry Experience and Skills
Throughout his career, Mahalingam Ramalingam has accumulated significant knowledge and expertise in regulatory affairs across various organizations. He has a detailed understanding of MDR, FDA, and Health Canada regulatory strategies. In prior roles with Novitium Pharma, Prism Pharmaceuticals, and Abbott, he has developed comprehensive skills in product development, key account management, and regulatory compliance. He is known for efficiently interpreting and applying regulatory standards and contributing to the development and approval of combination products and medical devices.